martes, 8 de septiembre de 2026
Underfunded And Understaffed, FDA Isn't Meeting Foreign Food Inspection Targets (+...)
Underfunded And Understaffed, FDA Isn't Meeting Foreign Food Inspection Targets
The cyclosporiasis outbreak has laid bare the shortcomings at the Food and Drug Administration, which lost inspectors during the covid pandemic and never recovered. Food experts say inspectors should have been on-site in Mexico at the farm tied to tainted lettuce sooner, considering the scale and number of people sickened, the AP reported.
https://kffhealthnews.org/morning-briefing/tuesday-september-8-2026/
Scientists, Scholars Pan HHS Report Linking Support For Trans People To Political Violence (+.. +)
https://kffhealthnews.org/morning-briefing/tuesday-september-8-2026/
Scientists, Scholars Pan HHS Report Linking Support For Trans People To Political Violence
"Where the Clinic Meets the Movement: Does Gender Ideology Arm Left-Wing Authoritarian Psychology?" — essentially a political ideology questionnaire, The Guardian reported — was neither peer-reviewed as required by law nor published by a scientific journal. “What we’re seeing is this broadside attack on the scientific establishment more generally, and trans rights are being used as the vehicle to do this,” one professor noted. Experts worry the administration might use the study to further its anti-trans campaign, The 19th reported.
https://kffhealthnews.org/morning-breakout/administration-news-090826/
With Midterms Looming, Journalists Consider Measles, Food Recalls, and Obamacare Aug. 29, 2026
https://kffhealthnews.org/on-air/on-air-august-29-2026-measles-vaccination-food-recalls-midterm-elections/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-98psW56O3NNVPsUR0ABg6ffjlaJaXmE3kyRau-gCCz5e5Niw75pA8CMvTyI1OZOIZgdNdfk3sGTKfGdaFYkZWX1Brsqw&_hsmi=437918065&utm_content=437918065&utm_source=hs_email
KFF Health News: With Midterms Looming, Journalists Consider Measles, Food Recalls, And Obamacare
Céline Gounder, KFF Health News’ editor-at-large for public health, discussed fatal measles cases on CBS News 24/7’s Mornings on Aug. 26. Gounder fact-checked Centers for Medicare & Medicaid Services Administrator Mehmet Oz’s comments about vaccines and drug prices on CBS News 24/7’s The Daily Report on Aug. 24. She also discussed food recalls this summer on CBS News 24/7’s The Takeout With Major Garrett on Aug. 24. KFF Health News chief Washington correspondent Julie Rovner discussed kindergarten vaccination rates on WNYC’s The Brian Lehrer Show on Aug. 25. KFF Health News contributor Mark Kreidler discussed the use of artificial intelligence for Medicaid reenrollment on KVPR’s Central Valley Daily on Aug. 24. KFF Health News senior correspondent Julie Appleby discussed the state of the Affordable Care Act on Vox’s Today, Explained podcast on Aug. 24. KFF Health News Georgia correspondent Briah Lumpkins discussed the importance of healthcare policy in upcoming elections on WUGA’s The Georgia Health Report on Aug. 21. (8/29)
The Market Forces Quietly Adding Thousands to Patient Bills By Elisabeth Rosenthal Sept. 8, 2026
https://kffhealthnews.org/news/vertical-integration-high-health-costs-prices-hospital-mergers-pharmacies-pbms/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--sZ6tUbJlzDPKPM3XahLR472WEu8DIp5vtci_GNDcRvulhHYWle07dwoDtm2Fo7Az_SzZKiDyudYoFr_zl479-hxzOIQ&_hsmi=437918065&utm_content=437918065&utm_source=hs_email
KFF Health News: The Market Forces Quietly Adding Thousands To Patient Bills
After a failed round of in vitro fertilization this year, Anne Hug’s fertility doctor said she had a single polyp in her uterus that should be removed to improve the chance of pregnancy. Hug, a professor of radiology, learned that the American College of Obstetricians and Gynecologists says the procedure can be done in a doctor’s office with local numbing. Her doctor referred her to a physician at the same hospital, which is part of a large Ohio health system. That doctor’s plan was to do the procedure in a hospital operating room, with anesthesia administered by an anesthesiologist. Hug balked at the $18,000 estimate. (Rosenthal, 9/8)
‘It’s Triage’: California’s Next Governor Will Face Destabilizing Surge in Uninsured By Christine Mai-Duc Sept. 8, 2026
https://kffhealthnews.org/elections/xavier-becerra-longtime-health-coverage-champion-california-gubernatorial-race-uninsured-rate/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-83uyNVbgaWLQmlSPgXT8k1FXEDNsRoMvl3Xu0kff9-pmCTlealiIiwc3FVY-9l65o8JyhD6YDwu_ToCRgcVwMTkDXAhg&_hsmi=437918065&utm_content=437918065&utm_source=hs_email
KFF Health News: ‘It’s Triage’: California’s Next Governor Will Face Destabilizing Surge In Uninsured
By the time Democrat Xavier Becerra left Washington, D.C., more Americans than ever had health insurance, owing partly to his work over the years to pass, defend, and expand the Affordable Care Act. It’s an achievement the former congressman and former U.S. secretary of Health and Human Services often touts as he campaigns for California governor against Republican Steve Hilton, a former Fox News commentator. (Mai-Duc, 9/8)
Global health and economic impact of expanding the WHO essential medicines list for psoriasis: a health economic modelling study Fatima Alia ∙ Alison K. Wrightb,q ∙ Thomas Graierc ∙ Mahira El Sayedd ∙ Rachel H. Gilese ∙ Jo Lambertf ∙ et al.
Global health and economic impact of expanding the WHO essential medicines list for psoriasis: a health economic modelling study
Fatima Alia ∙ Alison K. Wrightb,q ∙ Thomas Graierc ∙ Mahira El Sayedd ∙ Rachel H. Gilese ∙ Jo Lambertf ∙ et al.
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(26)00356-1/fulltext
Editorial Breastfeeding in Africa: mothers need enabling environments beyond education The Lancet Regional Health – Africa (+...)
Editorial
Breastfeeding in Africa: mothers need enabling environments beyond education
The Lancet Regional Health – Africa
https://www.thelancet.com/issue/S3050-5011(26)X2006-5
Editorial One population, many risks: rethinking youth suicide prevention in the Americas The Lancet Regional Health – Americas (+...)
Editorial
One population, many risks: rethinking youth suicide prevention in the Americas
The Lancet Regional Health – Americas
https://www.thelancet.com/issue/S2667-193X(26)X2005-1
Ultra-Processed Foods and Human Health (+... +...)
Ultra-Processed Foods and Human Health
This 3-paper Series reviews the evidence about the increase in ultra-processed foods in diets globally and highlights the association with many non-communicable diseases. This rise in ultra-processed foods is driven by powerful global corporations who employ sophisticated political tactics to protect and maximise profits. Education and relying on behaviour change by individuals is insufficient. Deteriorating diets are an urgent public health threat that requires coordinated policies and advocacy to regulate and reduce ultra-processed foods and improve access to fresh and minimally processed foods. The Series provides a different vision for the food system with emphasis on local food producers, preserving cultural foods transitions and economic benefits for communities.
https://www.thelancet.com/regional-health/eastern-mediterranean
Editorial Organ donation in India: a big gap to fill The Lancet Regional Health – Southeast (+...)
Editorial
Organ donation in India: a big gap to fill
The Lancet Regional Health – Southeast
https://www.thelancet.com/issue/S2772-3682(26)X2006-6
Editorial Protecting against genetic discrimination requires more than a law The Lancet Regional Health – Western Pacific (+...)
Editorial
Protecting against genetic discrimination requires more than a law
The Lancet Regional Health – Western Pacific
https://www.thelancet.com/issue/S2666-6065(26)X2006-5
Editorial p747 The far-reaching effects of wildfire smoke The Lancet Respiratory Medicine (+...)
Editorial
p747
The far-reaching effects of wildfire smoke
The Lancet Respiratory Medicine
https://www.thelancet.com/issue/S2213-2600(26)X2008-2
Editorial e675 Translating progress into patient benefit in dermatomyositis The Lancet Rheumatology (+...)
Editorial
e675
Translating progress into patient benefit in dermatomyositis
The Lancet Rheumatology
https://www.thelancet.com/issue/S2665-9913(26)X2008-2
Introducing The Lancet Surgery & Anaesthesiology (+...)
https://www.thelancet.com/surgery-anaesthesiology
“The founder of The Lancet, Thomas Wakley, was a surgeon and social reformer. From these beginnings The Lancet Group has been a pivotal platform advancing rigour in surgical science and equity in surgical care. I am delighted that the time has come for a dedicated home in The Lancet Surgery & Anaesthesiology, to serve as an ally for the best anaesthesiology, perioperative, and surgical science for better lives worldwide.”
Amy Slogrove, Editor-in-Chief, The Lancet Surgery & Anaesthesiology
Editorial The mechanism debate in psilocybin therapy for depression eBioMedicine (+...)
Editorial
The mechanism debate in psilocybin therapy for depression
eBioMedicine
https://www.thelancet.com/issue/S2352-3964(26)X2006-0
Editorial Heatwaves and health system resilience in Europe eClinicalMedicine (+...)
Editorial
Heatwaves and health system resilience in Europe
eClinicalMedicine
https://www.thelancet.com/issue/S2589-5370(26)X2008-9
A digital intervention to protect cognitive health in older adults with cognitive impairment: a three-arm, open-label, randomised controlled trial Prof Paul Little, FRCGP FMedScia Send email to p.little@soton.ac.uk ∙ Rosie Essery, PhDa ∙ Jane Somerville, MSca ∙ Taeko Becque, PhDa ∙ Victoria Hayter, PGDipa ∙ Prof Beth Stuart, PhDg ∙ et
A digital intervention to protect cognitive health in older adults with cognitive impairment: a three-arm, open-label, randomised controlled trial
Prof Paul Little, FRCGP FMedScia Send email to p.little@soton.ac.uk ∙ Rosie Essery, PhDa ∙ Jane Somerville, MSca ∙ Taeko Becque, PhDa ∙ Victoria Hayter, PGDipa ∙ Prof Beth Stuart, PhDg ∙ et
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(26)00088-9/fulltext?dgcid=raven_jbs_etoc_feature_lanprc
Major adverse cardiovascular events and mortality associated with ADHD and its treatment in adults with hypertension: a retrospective, multinational cohort study Yiling Zhou, MResa,∗ Send email to y.zhou01@umcg.nl ∙ Zihan Dong, MScb,∗ ∙ Aske Astrup, MScc,d ∙ Prof Anders Engeland, PhDe,f ∙ Malcolm B Gillies, PhDg ∙ Astrid Lunde, PhDf ∙ et al.
Major adverse cardiovascular events and mortality associated with ADHD and its treatment in adults with hypertension: a retrospective, multinational cohort study
Yiling Zhou, MResa,∗ Send email to y.zhou01@umcg.nl ∙ Zihan Dong, MScb,∗ ∙ Aske Astrup, MScc,d ∙ Prof Anders Engeland, PhDe,f ∙ Malcolm B Gillies, PhDg ∙ Astrid Lunde, PhDf ∙ et al.
https://www.thelancet.com/journals/lanprc/article/PIIS3050-5143(26)00085-3/fulltext?dgcid=raven_jbs_etoc_feature_lanprc
Primary and community care for a changing climate The Lancet Primary Care +...
Primary and community care for a changing climate
The Lancet Primary Care
https://www.thelancet.com/journals/lanprc/issue/vol2no8/PIIS3050-5143(26)X2008-8
FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 2026 By Sarah Wicks & Deborah L. Livornese & Michelle L. Butler —
https://www.thefdalawblog.com/2026/09/fda-and-sec-compare-notes-what-the-new-mou-means-for-fda-regulated-public-companies/?utm_source=rss&utm_medium=rss&utm_campaign=fda-and-sec-compare-notes-what-the-new-mou-means-for-fda-regulated-public-companies
On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for three years and can be extended.
For publicly traded life sciences companies, the immediate implication seems obvious: SEC may have an easier way to learn what FDA knows when evaluating what a company has told investors about clinical trial results, regulatory interactions, product approvals, or other FDA-related developments.
But FDA and SEC have been sharing this kind of information for more than two decades. So, what exactly is new?
lunes, 7 de septiembre de 2026
Editorial Ménière's disease: the treatment evidence we still do not have The Lancet Regional Health – Europe (+...)
Editorial
Ménière's disease: the treatment evidence we still do not have
The Lancet Regional Health – Europe
https://www.thelancet.com/issue/S2666-7762(26)X2005-1
Editorial e583 Accelerating action on road safety The Lancet Public Health (+...)
Editorial
e583
Accelerating action on road safety
The Lancet Public Health
https://www.thelancet.com/issue/S2468-2667(26)X2008-4
Editorial 1 year of The Lancet Primary Care The Lancet Primary Care (+...)
Editorial
1 year of The Lancet Primary Care
The Lancet Primary Care
https://www.thelancet.com/issue/S3050-5143(26)X2007-6
Editorial Biodiversity: actions lagging behind aspirations The Lancet Planetary Health (+...)
Editorial
Biodiversity: actions lagging behind aspirations
The Lancet Planetary Health
https://www.thelancet.com/issue/S2542-5196(26)X2006-X
Editorial p1057 Beyond cancer: The Right to be Forgotten The Lancet Oncology (+...)
Editorial
p1057
Beyond cancer: The Right to be Forgotten
The Lancet Oncology
https://www.thelancet.com/issue/S1470-2045(26)X2008-3
Editorial e751 Cervical cancer elimination: progress made, but not for all The Lancet Obstetrics, Gynaecology, & Women's Health (+...)
Editorial
e751
Cervical cancer elimination: progress made, but not for all
The Lancet Obstetrics, Gynaecology, & Women's Health
https://www.thelancet.com/issue/S3050-5038(26)X2008-8
Editorial p789 Epilepsy care must look beyond seizure control The Lancet Neurology (+...)
Editorial
p789
Epilepsy care must look beyond seizure control
The Lancet Neurology
https://www.thelancet.com/issue/S1474-4422(26)X2007-5
Editorial The human gut microbiome: still more questions than answers The Lancet Microbe (+...)
Editorial
The human gut microbiome: still more questions than answers
The Lancet Microbe
https://www.thelancet.com/issue/S2666-5247(26)X2007-9
Editorial Seeing further, together The Lancet Medical Imaging & Theranostics
Editorial
Seeing further, together
The Lancet Medical Imaging & Theranostics
https://www.thelancet.com/issue/S3117-4523(26)X2001-9
Editorial p871 Oral carbapenem—a double-edged sword? The Lancet Infectious Diseases (+...)
Editorial
p871
Oral carbapenem—a double-edged sword?
The Lancet Infectious Diseases
https://www.thelancet.com/issue/S1473-3099(26)X2008-4
Editorial e611 Will the new UN political declaration deliver? The Lancet HIV (+...)
Editorial
e611
Will the new UN political declaration deliver?
The Lancet HIV
https://www.thelancet.com/issue/S2352-3018(26)X2008-2
Editorial Ending preventable heat-related deaths among older adults The Lancet Healthy Longevity (+...)
Editorial
Ending preventable heat-related deaths among older adults
The Lancet Healthy Longevity
https://www.thelancet.com/issue/S2666-7568(26)X2007-4
Editorial e603 Beyond maximum grade: a decade in the making The Lancet Haematology (+...)
Editorial
e603
Beyond maximum grade: a decade in the making
The Lancet Haematology
https://www.thelancet.com/issue/S2352-3026(26)X2008-7
Editorial Small island developing states on the frontline The Lancet Global Health (+...)
Editorial
Small island developing states on the frontline
The Lancet Global Health
https://www.thelancet.com/issue/S2214-109X(26)X2007-1
Editorial p863 Blood-based CRC screening: closer, but not there yet The Lancet Gastroenterology & Hepatology (+...)
Editorial
p863
Blood-based CRC screening: closer, but not there yet
The Lancet Gastroenterology & Hepatology
https://www.thelancet.com/issue/S2468-1253(26)X2008-8
Editorial Oculomics and the search for brain biomarkers The Lancet Digital Health (+...)
Editorial
Oculomics and the search for brain biomarkers
The Lancet Digital Health
https://www.thelancet.com/issue/S2589-7500(26)X2008-8
Editorial p703 Soaring GLP-1 receptor agonist use The Lancet Diabetes & Endocrinology (+...)
Editorial
p703
Soaring GLP-1 receptor agonist use
The Lancet Diabetes & Endocrinology
https://www.thelancet.com/issue/S2213-8587(26)X2007-1
Editorial p687 Protect young people from the peptide boom The Lancet Child & Adolescent Health (+...)
Editorial
p687
Protect young people from the peptide boom
The Lancet Child & Adolescent Health
https://www.thelancet.com/issue/S2352-4642(26)X2008-9
Editorial p867 Reimagining maternal cardiovascular health The Lancet (+...)
Editorial
p867
Reimagining maternal cardiovascular health
The Lancet
https://www.thelancet.com/issue/S0140-6736(26)X2033-5
Have you read our ESC Congress 2026 content? (+...)
Catheter ablation for symptomatic atrial fibrillation
Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial
Rolf Wachter, MDa Send email to rolf.wachter@medizin.uni-leipzig.de ∙ Patrick Haag, MDb ∙ Tobias Uhe, MDa ∙ Miroslav Bacak, PhDc ∙ David Petroff, PhDc ∙ Mathias Forkmann, MDd ∙ et al.
(PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial
Open Access
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01558-8/fulltext?dgcid=hubspot_email_conferencealerts_esc26&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-_4KbNX9GG0sIBon7IXi5txJPr778uNuxgLTq-Twtu4Czr9JeAnoYcOcXgTsGsD7AzYUgkfSLfToRbMHyl-VKaC6CF_Sw&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Aetiology, management, and outcomes of acute heart
failure in 17 African countries (THESUS-HF II): a prospective,
multicentre, observational cohort study
Free with registration until Sept 8th, 2026
Aetiology, management, and outcomes of acute heart failure in 17 African countries (THESUS-HF II): a prospective, multicentre, observational cohort study
Prof Karen Sliwa, MD PhDa,* Send email to karen.sliwa-hahnle@uct.ac.za ∙ Julia Hahnle, MDa,* ∙ Prof Simon Stewart, MDe ∙ Shaazia Allie, MDa ∙ Prof Albertino Damasceno, MD PhDb ∙ Duard Smita,c ∙ et al.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01657-0/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-82o-8ftcrIHVYlBS9gHFTPCjbc2U_3vDgesRNqQ-t9BoPdGPkm3M0cjJqotTVbenGIfxx47hGM_h3SPYBI9y6z-Ysksw&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Discontinuation of β-blockers in stable patients with
previous myocardial infarction, preserved left ventricular
ejection fraction, and no heart failure: a pooled analysis of
individual patient data
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01426-1/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-9oMOeWl36jVJnzvOWtfuVgZZKC8W6EZbSEo2JbkXddoIo3l1aKrdMzYelwSrzKGMAxvbmn9mc99soJzZfIXYYfiRA8dQ&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration until Sept 8th, 2026
Safety and lipoprotein(a)-lowering effects of Kylo-11, a non-canonical, long-duration small interfering RNA targeting
lipoprotein(a): a first-in-human, randomised, double-blind,
placebo-controlled, phase 1 trial
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01484-4/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-9V8CgA4_A6BWwFT2ZwraWbpk2M7_ikrqwrfOhaMtDBTF6HcYJ6QJsPPkkqXOwVFT2QQBSEREvNlIoIWLBLnL8Wh2RLBw&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration until Sept 8th, 2026
Safety and efficacy of the 0/1 h pathway for myocardial
infarction in the emergency department: an international,
pragmatic, stepped-wedge, cluster-randomised, controlled
trial
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01654-5/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-_-fdacbtFc1vXK8MQQipRYGCkXpijnZ9LbZF4OxMubXVTC0qh1d6FfZAbPadXHQY8VGOMnZY7nRW4T27wFOWz_bgHeWw&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration until Sept 8th, 2026
Targeted left ventricular lead placement in biventricular
pacing for heart failure: a national, multicentre, double-blind, randomised controlled trial in Denmark
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01597-7/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-_nmppg2_wL1OALk-iw_mGm7k5a-O8PdVSaf_nPRhr7JX-qHoiL88oc92dq9NQ43M5o3WJNXzpRY9UOpJKqbjTVH_cG0A&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration until Sept 8th, 2026
Multimodal artificial intelligence-based long-term mortality
prediction after transcatheter aortic valve implantation:
a multicentre development, validation, and testing study
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(26)00072-5/fulltext?dgcid=hubspot_email_conferencealerts_esc26&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-_94EOnoD86hYv3UpNC80uHfP2Lr_LjEra5cWZP6s8iENMc8aWcbNSgDKrE6x3NbB7EvNBa6_cdO74c7w2wGFUx368WRg&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Open Access
Contributions of diet and lifestyle to sex differences in
ischaemic heart disease burden in Central Europe: an analysis
of the Global Burden of Disease Study 2023
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(26)00258-9/fulltext?dgcid=hubspot_email_conferencealerts_esc26&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-8NH95b3jQhZSwKf-D6fpgmuckkH5U0pIO_7aXu-bqjiTkDSkXIA9A0HFwIF3F9nHTQVsqZeATiXH6ItUULAfTdAVthZw&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Open Access
SERIES
Cardiovascular disease in pregnancy: physiology, global
burden, risk stratification, and opportunities in care
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01234-1/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-84015CiFfyB68ezI5uJ6ml3EWLIQ7MZwFcDXRKSGU-0BJXm5Q53de3m4DdnbaAhEn91Wl7gWAOk-ndI2jILiQVHBWKHg&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration
Adverse pregnancy outcomes and long-term cardiovascular
disease risk
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01235-3/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-8fgfBf_yAtWIFI5TMPABKW9CT17mkQqmQKBJihV0j8gIBfZLSTTwSp0marJJYU5JjhNGXacP61vIaOzX70L3drAeRk3A&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration
Hypertensive disorders of pregnancy: risk stratification and
management
https://www.thelancet.com/journals/lanogw/article/PIIS3050-5038(26)00190-1/abstract?utm_campaign=conferencealerts&utm_medium=email&dgcid=hubspot_email_conferencealerts_esc26&_hsenc=p2ANqtz-8USnv_aXLOzwLCkWJacFU1mmxq3qWENnjJ0o0vsx1ojYx3WhI6jayIpe6p3WAYemprVwbzo2EsQfEdqfOzuzTyx-3q7A&_hsmi=437695803&utm_content=437464180&utm_source=hs_email
Free with registration
domingo, 6 de septiembre de 2026
Multi-source data-driven machine learning improves lung cancer care
https://www.news-medical.net/news/20260817/Multi-source-data-driven-machine-learning-improves-lung-cancer-care.aspx?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
Section 1: Background
Lung cancer remains one of the malignancies with the highest incidence and mortality worldwide. Clinical practice has long been plagued by core dilemmas, including insufficient sensitivity in early screening, lack of personalized treatment regimens, and limited accuracy in prognostic evaluation, which severely restrict the improvement of patient survival rates. Traditional lung cancer diagnosis and treatment rely heavily on empirical judgment, which can hardly address the high heterogeneity of tumors and the complex evolution of the disease course. With the continuous accumulation of medical resources such as medical imaging, omics detection, liquid biopsy, digital pathology, and electronic health records, lung cancer management has entered a new era driven by multi-source data. Machine learning, with its powerful capabilities in data mining and pattern recognition, can extract latent patterns from complex, heterogeneous, and multi-dimensional medical data. It transforms morphological features, molecular characteristics, pathological structures, blood biomarkers, and clinical information into quantitative evidence for diagnosis, treatment decision-making, and prognosis assessment, thus becoming a key technology to break through the bottlenecks of lung cancer care.
New machine learning model improves accuracy of prenatal genetic testing
https://www.news-medical.net/news/20260811/New-machine-learning-model-improves-accuracy-of-prenatal-genetic-testing.aspx?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
Advances in genome sequencing are giving more families access to prenatal genetic testing and new information about an unborn baby's health, including whether genetic changes may link to a neurodevelopmental condition.
Machine learning model can identify likely non-responders to exercise-based cardiac rehabilitation
Exercise training is a cornerstone of cardiac rehabilitation (CR) for patients with coronary artery disease (CAD), and current guidelines rate it as a top-tier recommendation for reducing the risk of future cardiovascular events. Yet a substantial share of patients, often estimated at one in five or more, show little or no measurable improvement in their exercise capacity despite completing a full rehabilitation program. Identifying these "non-responders" before training begins could allow clinicians to adjust treatment plans early, rather than discovering the lack of benefit only after weeks of therapy have passed.
https://www.news-medical.net/news/20260821/Machine-learning-model-can-identify-likely-non-responders-to-exercise-based-cardiac-rehabilitation.aspx?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
AI and Intelligent Photonics Could Advance Panvascular Interventions
https://www.azooptics.com/News.aspx?newsID=30771&utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
Researchers have highlighted significant advancements in cardiovascular medicine that can arise from integrating high-resolution optical imaging, artificial intelligence (AI), and digital twins into a unified framework for panvascular interventions.
Nanoglass Interfaces Expand the Design Space for Amorphous Materials
https://www.azonano.com/news.aspx?newsID=41791&utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
Nanoscale glass-glass interfaces with unusually high excess volume could give researchers new control over atomic transport, mechanical behavior, and functional properties beyond the limits of conventional glasses.
Industry Focus eBook - Metals Analysis (1st edition)
https://www.azom.com/industry-focus/Industry-Focus-eBook-Metals-Analysis-(1st-edition)
Metals are at the heart of modern innovation, powering sectors from manufacturing and infrastructure to food production and energy.
As sustainability, performance, and safety standards continue to rise, metals analysis is increasingly crucial in advancing materials science and engineering, using cutting-edge tools and techniques that redefine what is possible.
In this latest edition of the Metals Analysis Industry Focus eBook, AZoM brings together top articles, expert insights, and the latest research highlights from the past year.
Industry Focus eBook - Surface Metrology (1st Edition)
https://www.azom.com/industry-focus/Surface-Metrology--Industry-Focus-eBook
Discover the latest advances in surface characterization with this exclusive eBook on Surface Metrology and Measurement, developed in collaboration with Bruker Nano Surfaces. This curated collection explores the tools, techniques, and technologies driving precision in industries from biomedical engineering to aerospace.
Through expert articles, practical case studies, and technology spotlights, readers will gain valuable insight into 3D profiling, white-light interferometry, advanced optical metrology, and the evolving standards that guide quality assurance.
Shaping the Future of Industrial Measurement with ABB’s Instrumentation Book of Innovations
https://www.azom.com/industry-focus/Shaping-the-Future-of-Industrial-Measurement-with-ABB%e2%80%99s-Instrumentation-Book-of-Innovations
From the early days of mechanical and electromechanical instruments to today’s advanced digital sensors, ABB has aimed not just to meet market needs, but to stay one step ahead.
Whether it's improving accuracy, enhancing reliability, or simplifying operation, ABB’s history is marked by innovations that have continually raised the bar—delivering higher performance and setting new industry standards.
Editorial Focus eBook - Advanced Materials (3rd Edition)
https://www.azom.com/industry-focus/Editorial-Focus-eBook-Advanced-Materials-(3rd-Edition)
Advanced materials research is moving quickly, as new advances in design, fabrication, and characterization open up fresh possibilities. From responsive polymers to nanoengineered architectures, scientists and engineers are expanding what materials can do and how they can support the technologies of tomorrow.
In our latest Advanced Materials Editorial Focus eBook, we’ve brought together a selection of research highlights and expert perspectives that reflect the energy and creativity driving modern materials science.
The Complete Guide to AI Data Foundations
https://www.azom.com/industry-focus/The-Complete-Guide-to-AI-Data-Foundations?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=medtech_newsletter_24_august_2026
Artificial intelligence is creating new opportunities across R&D, product lifecycle management, and quality control. However, the value of AI depends heavily on the quality, structure, and accessibility of the data behind it.
For many product development teams, critical information remains scattered across spreadsheets, LIMS, ELNs, reports, paper records, and disconnected business systems. This fragmentation can limit collaboration, make previous work difficult to find, and prevent organizations from generating reliable insights from analytics and AI.
The $22 Billion Surprise Inside the No Surprises Act | Jack Hoadley Jeff ByersandJack Hoadley September 4, 2026
https://www.healthaffairs.org/do/10.1377/hp20260903.585609/full/?utm_campaign=podcast&utm_medium=email&_hsenc=p2ANqtz-8n9f2vd58YVW17v_-Z2JlJD7pLzhkOZq8jQMq81PCmBVarBCag960N8-K-kHj9IFAstj0xf2C91rihKNdh4c4W47n7XA&_hsmi=437531976&utm_content=hatw&utm_source=hasu
Jack Hoadley of Georgetown University breaks down how the No Surprises Act’s dispute resolution process has grown into a $22.4 billion system and what it could mean for healthcare costs and premiums.
Dhruv Khullar on Public Health, Pandemic Preparedness & the Future of Healthcare Dhruv KhullarandRob Lott September 1, 2026
https://www.healthaffairs.org/do/10.1377/hp20260827.106171/full/?utm_campaign=podcast&utm_medium=email&_hsenc=p2ANqtz-83MfQ1duGkHRulsYWint7yvXtpwz6VjI1detrkLp2dP8CmSSKImUoKcW8hQeNZWBFfddhVetVW9pv23gWRdCmR1lIUKQ&_hsmi=437531976&utm_content=ahp&utm_source=hasu
Dhruv Khullar joins the show to discuss the nation's readiness for future public health threats, the challenges facing disease surveillance, and how his work spans medicine, policy, and journalism.
Artificial Intelligence and Health Care: What’s Next Paige Nong,Jonathan D. Ketcham,Halle Tecco,andMichael S. Gerber September 16, 2026, 11:00 AM
https://www.healthaffairs.org/do/10.1377/he20260819.334088/full/?utm_campaign=insidermarketing&utm_medium=email&_hsenc=p2ANqtz-_-zyWNd6ovBa4rpCShgdSSrwMcLHK5QvQEXadGkt7Hu9t2Ca6dRpBBc9Ctc--ULlJG1A1FR1pdcFfr8ayhCdEBzhCtLQ&_hsmi=437531976&utm_content=eventspecific&utm_source=hasu
What's the next wave of considerations the health care field should weigh regarding the use and impact of artificial intelligence? Halle Tecco, Paige Nong, and Jonathan Ketcham examine AI's greatest potential in health care, and where it can see the best ROI.
The artificial intelligence (AI) era in health care is here.
Where might we see the biggest impacts, and where might policymakers and health system leaders see the biggest ROI?
In this Insider-only event moderated by senior editor Michael Gerber, leaders in the venture capital and health economics space open up about their perspectives on AI, health care, and where the two are heading.
Panelists included Halle Tecco, venture capitalist and author of Massively Better Healthcare, Jonathan Ketcham of Arizona State University, and Paige Nong of the University of Minnesota.
Date: September 16, 2026
Time: 11:00am - 12:00pm ET
Brain drain: Israel’s medical exodus grows as nearly 1,400 doctors leave inside three years ByJERUSALEM POST STAFF + +...
Brain drain: Israel’s medical exodus grows as nearly 1,400 doctors leave inside three years
In 2023, 416 doctors left Israel for at least one year, compared with 530 in 2024 and a preliminary estimate of 419 in 2025.
ByJERUSALEM POST STAFF
SEPTEMBER 6, 2026 13:00
Updated: SEPTEMBER 6, 2026 13:33
https://www.jpost.com/health-and-wellness/article-907691
Nine-year-old boy in serious condition after infection caused by brain-eating amoeba
The boy was hospitalized with swelling in his brain and was subsequently sedated and ventilated in intensive care at Rambam Hospital.
https://www.jpost.com/health-and-wellness
ByDANYA SAPERSTEIN
SEPTEMBER 6, 2026 13:51
sábado, 5 de septiembre de 2026
Fifth Circuit Invalidates Two More Provisions Of No Surprises Act Rule Katie KeithandEllie DeGarmo September 1, 2026
https://www.healthaffairs.org/content/forefront/fifth-circuit-invalidates-two-more-provisions-no-surprises-act-rule
The Trump administration might use the court’s decision to justify additional regulatory changes to the QPA methodology. Another question is whether the decision will prompt Congress to revisit the NSA, especially as its costs rise.
Analyzing The Federal Trade Commission’s Pharmacy Benefit Manager Settlements Michael A. CarrierandRachel Sachs September 2, 2026
https://www.healthaffairs.org/content/forefront/analyzing-federal-trade-commission-s-pharmacy-benefit-manager-settlements
Despite the FTC’s promises, its settlements with PBMs will not be fully effective at accomplishing their stated goals. One concern of note: The settlements neglect the recent development of PBMs marketing their own drugs.
Dental Insurance Has The Wrong Maximum Habib Benzian September 1, 2026
https://www.healthaffairs.org/content/forefront/dental-insurance-has-wrong-maximum
CMS should let states insure adult dental care differently.
New SAMHSA Requirements Threaten Opioid Use Disorder Treatment And Overdose Prevention Maureen Stewart,Alisa B. Busch,Sage R. Feltus,Sharon Reif,Traci C. Green,andRichard G. Frank September 1, 2026
https://www.healthaffairs.org/content/forefront/undermining-recovery-new-samhsa-requirements-threaten-opioid-use-disorder-treatment-and
The health care system must engage people in treatment, provide them with care that is likely to set them on a path to recovery, and ensure that they have continued support. New federal agency requirements threaten those efforts.
Designing Bilateral Medicare-Medicaid Risk Contracts In The New ACO LEAD Model Eric T. Roberts,Kenton J. Johnston,Karen E. Joynt Maddox,Rachel M. Werner,Allison M. Nishi,andJosé F. Figueroa September 2, 2026
https://www.healthaffairs.org/content/forefront/designing-bilateral-medicare-medicaid-risk-contracts-new-aco-lead-model
CMS and state Medicaid agencies should consider several factors related to the ACO LEAD (ACO Long-Term Enhanced Design) model’s proposed test of integrated Medicare-Medicaid ACOs.
340B Could Inflate Spending In The CMS Bridge Program By More Than A Billion Dollars Stacie B. Dusetzina,Sayeh Nikpay,andBrian Reid August 27, 2026
https://www.healthaffairs.org/content/forefront/340b-could-inflate-spending-cms-bridge-program-more-than-billion-dollars
The existence of duplicative discounts in the Bridge Program likely represents an unintended consequence of its design that could inflate the price tag of the coverage expansion without any corresponding benefit.
AI Can Lower Costs, But Only If Properly Applied Ken Terry August 27, 2026
https://www.healthaffairs.org/content/forefront/ai-can-lower-costs-but-only-if-properly-applied
A response to “Why AI Will Accelerate Health Care Inflation” and “Health Care Inflation Means Quality-Adjusted Price Growth, And Artificial Intelligence Can Reduce It.”
From Children To Adults: The Government’s Expanding Attack On Gender-Affirming Care Richard Hughes IV,Eric J. Neiman,Jennifer M. Nelson Carney,andJulia Rioux Thayer September 3, 2026
https://www.healthaffairs.org/content/forefront/children-adults-government-s-expanding-attack-gender-affirming-care
The distinction between prohibiting gender-affirming care for minors and restricting gender-affirming care for adults is no longer holding.
Public Charge Restrictions For Immigrants And Their Families: No Rules, No Accountability Leighton Ku September 3, 2026
https://www.healthaffairs.org/content/forefront/public-charge-restrictions-immigrants-and-their-families-no-rules-no-accountability
The final “public charge” rule broadens the range of benefits used in determining public charge status, allows officials to consider benefits used by family members, and eliminates regulatory guardrails regarding the public charge determination and appeal rights.
The National Hepatitis C Plan Needs A Correctional-Care Standard Y. Tony Yang September 4, 2026
https://www.healthaffairs.org/content/forefront/national-hepatitis-c-plan-needs-correctional-care-standard
Access to medication is not the same as delivery of a cure. Without defined delivery obligations, federal funds risk financing treatment courses rather than completed cures.
Subscription Drug Pricing: The Evidence Behind It Comes From Two States, And They Disagree. Zizi ElsisiandAnirban Basu September 4, 2026
https://www.healthaffairs.org/content/forefront/subscription-drug-pricing-evidence-behind-comes-two-states-and-they-disagree
If CMS is to write a template for other states, or if Congress is to buy this design at national scale, it is important to understand why these policies may fail to deliver expected outcomes.
Health Services Professionals Endorse Omitting Some Research Information Under Limited Circumstances: Survey Authors: Alan S. Gerber, Mackenzie Lockhart, Eric M. Patashnik, and Harold A. Pollack
https://www.healthaffairs.org/doi/10.1377/hlthaff.2025.01440
In an era of polarization, misinformation, and declining public trust in experts, effective public communication about health research is essential for disseminating evidence and maintaining the credibility of the research enterprise. Yet when communicating research findings to general audiences, experts face dilemmas about whether to omit information to avoid public confusion, to prevent the stigmatization of marginalized constituencies, or to keep information from being weaponized against vulnerable groups. Drawing on a national survey of health services professionals conducted in April and May 2025, we found that respondents generally rejected omissions serving self-protective or politically strategic ends but accepted omissions aimed at preventing public confusion or harm to marginalized groups. There is meaningful variation in support for these justifications by ideology, education, and workplace. In weighted regressions, conservatives, PhD holders, and those working outside academia in government or other nonuniversity settings were less likely to endorse omissions as justified compared with liberals and moderates, non-PhDs, and university-based researchers. These findings reveal both common ground and meaningful division in how professionals view transparency, underscoring the need for research on actual communication behavior and guidance to help experts navigate these dilemmas.
UC Riverside receives grant to evaluate California’s traditional health care practices benefit
https://www.news-medical.net/news/20260904/UC-Riverside-receives-grant-to-evaluate-Californiae28099s-traditional-health-care-practices-benefit.aspx
A $1.25 million grant to UC Riverside from the California Department of Health Care Services (DHCS) will support a statewide evaluation of California's traditional health care practices (THCP) benefit.
Business of Medicine News (+...)
Business of Medicine News
Pharmacies Call for Tougher Response to Increasing Crime
An NPA survey found most pharmacies faced shoplifting, break-ins, or abuse last year, and almost a third did not report incidents to police.
Medscape News UK, September 04, 2026
https://www.medscape.com/index/list_13469_0
Parkinson’s disease imposes €22.8 billion economic burden across Europe
https://www.news-medical.net/news/20260827/Parkinsone28099s-disease-imposes-e282ac228-billion-economic-burden-across-Europe.aspx?utm_source=news_medical_newsletter&utm_medium=email&utm_campaign=parkinson_s_disease_newsletter_2_september_2026
The annual societal cost of Parkinson's disease across Europe reached €22.8 billion in 2019, equivalent to €28.8 billion at 2025 prices, a new study published today in Movement Disorders has shown. As the number of people living with Parkinson's disease continues to grow, researchers warn that health and social care systems are likely to face increasing pressure.
ART-conceived children show reassuring long-term health outcomes
https://www.news-medical.net/news/20260904/ART-conceived-children-show-reassuring-long-term-health-outcomes.aspx
The birth of Louise Brown in 1978, the world's first baby conceived through assisted reproductive technology (ART), was a major breakthrough that reshaped the field of reproductive medicine. Today, over 10 million children worldwide have been born through ART procedures, and experts estimate that around one in every 12 babies in Europe and one in every 20 in the USA are conceived artificially. As these numbers continue to rise, so does our responsibility to understand the impact on the long-term health of children born using these techniques.
How Plant Biosensors, IoT, and AI Are Advancing Precision Agriculture
https://www.news-medical.net/life-sciences/How-Plant-Biosensors-IoT-and-AI-Are-Advancing-Precision-Agriculture.aspx
Plant-wearable biosensors, IoT connectivity, and AI are shifting precision agriculture from reactive crop management to continuous, data-driven decision-making. Despite challenges related to sensor reliability, interoperability, and large-scale deployment, these technologies are laying the foundation for smarter irrigation, earlier disease detection, and more sustainable farming.
Against the backdrop of ever-increasing climate instability and recent reports that predict a 70% global food demand increase by 2050, reviews assessing the state of modern agriculture emphasize that the most pressing need in the field is the development of transformative crop monitoring systems capable of detecting physiological stress before visible symptoms occur, thereby supporting earlier and more targeted interventions.
FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative?utm_medium=email&utm_source=govdelivery
On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment?utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
FDA granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.
ESR1 mutations are acquired resistance mutations that a tumor may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have this tumor mutation. After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have this tumor mutation.
“Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
The accelerated approval program allows for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on surrogate or intermediate endpoints. In this case, accelerated approval of Etcamah was granted based on how long patients lived without their disease worsening, measured from the point when the resistance mutation was first detected in the blood. Since it is not yet confirmed whether intervening at this point, rather than at the time of confirmed disease progression, translates into a clinically meaningful benefit, the FDA has required confirmatory studies to verify and describe clinical benefit.
“I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing. But additional evidence is needed to confirm clinical benefit.”
ctDNA is made up of tiny pieces of tumor DNA released into the blood, which can allow for earlier molecular detection of resistance mutations.
To ensure precise patient matching, the FDA also authorized the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with camizestrant.
Efficacy was evaluated in a clinical trial to assess switching to Etcamah, an oral tablet, in combination with a CDK4/6 inhibitor versus continuing an aromatase inhibitor in combination with a CDK4/6 inhibitor. Estimated median progression-free survival was 16 months in the Etcamah and CDK4/6 inhibitor arm and 9.2 months in the aromatase inhibitor and CDK4/6 inhibitor arm.
The prescribing information includes a boxed warning for the risk of irregular heart rhythm when Etcamah is taken together with certain other medications, as well as warnings and precautions for an abnormally slow heart rate and potential harm to an unborn baby.
Full prescribing information for Etcamah will be posted on Drugs@FDA.
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates Guidance for Industry September 2026
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policies-compounding-certain-starter-parenteral-nutrition-drug-products-neonates?utm_medium=email&utm_source=govdelivery
The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube.
The FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
“The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.”
In response, the FDA assessed the situation and identified ways to help prevent a disruption in supply. As part of that effort, the agency is issuing an immediately-in-effect guidance, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates, describing the agency’s temporary regulatory and enforcement priorities regarding certain compounded starter parenteral nutrition drug products. The guidance is intended to help address potential supply gaps and support hospitals in continuing to access critical nutrition drug products while longer-term solutions are identified.
“Starter parenteral nutrition is especially important for premature and critically ill newborns who need nutrition soon after birth,” said Michael Davis, M.D., Ph.D., Acting Center Director of FDA’s Center for Drug Evaluation and Research. “These temporary policies are intended to help hospitals maintain access to this life-saving nutrition during this transition.”
The guidance describes regulatory and enforcement priorities for certain state-licensed pharmacies, federal facilities and outsourcing facilities that compound specified parenteral drugs under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
The FDA will continue to monitor current and expected supply needs and assess if additional action is needed as the situation develops.
viernes, 4 de septiembre de 2026
Editorial p867 Reimagining maternal cardiovascular health The Lancet (+...)
Editorial
p867
Reimagining maternal cardiovascular health
The Lancet
https://www.thelancet.com/journals/lancet/issue/vol408no10558/PIIS0140-6736(26)X2033-5
The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat
The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat
Georgiana M Gordon-Strachan, PhDa Send email to georgiana.gordonstrachan@uwi.edu ∙ Stephanie Y Parker, MSca ∙ Heather C Harewood, MDc ∙ Kimalie F Parchment, BSca ∙ David C Smith, PhDb ∙ Pablo Mendez-Lazaro, PhDe,f ∙ et al.
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00106-3/fulltext?dgcid=raven_jbs_etoc_feature_langlo
The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study
The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study
Shatha Elnakib, PhDa,b Send email to selnaki1@jhu.edu ∙ Timothy Roberton, DrPHc,d ∙ Husnia Sadat, MPHd ∙ Supriya Madhavan, PhDd ∙ Hadia Samaha, MAf ∙ Mohammad Mahdi Frough, MAe ∙ et al.
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00135-X/fulltext?dgcid=raven_jbs_etoc_feature_langlo
Small island developing states on the frontline The Lancet Global Health + +...
Small island developing states on the frontline
The Lancet Global Health
https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00253-6/fulltext?dgcid=raven_jbs_etoc_email
Sep 2026
Volume 14Number 9
https://www.thelancet.com/journals/langlo/issue/vol14no9/PIIS2214-109X(26)X2007-1
Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026
https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-modernizing-bioequivalence-approaches-topical-transdermal?utm_medium=email&utm_source=govdelivery
Virtual Workshop
Advancing Generic Drug Development:
Modernizing Bioequivalence Approaches for Topical & Transdermal Products
Thursday, September 10, 2026, 8:30 a.m. to 12:40 p.m. (EDT)
Join via Adobe Connect: Advancing Generic Drug Development 2026: Modernizing Bioequivalence Approaches
This virtual event is FREE!
Are you developing a topical or transdermal generic drug product? Join this half-day virtual workshop to hear FDA experts discuss current regulatory recommendations, emerging bioequivalence approaches, and research that is helping streamline generic drug development and review.
Attendees can ask questions and learn from case examples showing how GDUFA-funded research has informed guidance revisions and ANDA assessments. The workshop will also address characterization-based approaches, modeling and simulation, in vitro permeation testing (IVPT) method development, and recommendations for topical and transdermal delivery systems.
https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/5118822171/event_registration.html?_charset_=utf-8&sco-id=7126601038&utm_medium=email&utm_source=govdelivery
Topics
Current recommendations, implementation challenges, and alternative bioequivalence approaches for topical products.
Case examples showing how GDUFA-funded research has informed guidance revisions, reduced submission deficiencies, and supported ANDA assessments.
How empirical and in silico research supports product-specific guidances and characterization-based bioequivalence approaches, including robust IVPT method development.
Recommendations and implementation strategies for topical and transdermal delivery systems, including how to determine when in vivo studies such as sensitization studies are appropriate
Audience
Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and others who work on or have an interest in the development of topical and transdermal generic drug products.
Ionis wins FDA approval for first drug for Alexander disease, a rare and deadly neurological disorder Alexander disease is extraordinarily rare, so Ionis took an unusual approach to testing its drug
https://www.statnews.com/2026/09/03/ionis-fda-approval-zanvastro-alexander-disease/
By Jonathan WosenSept. 3, 2026
West Coast Biotech & Life Sciences Reporter
The FDA removed the red tape around one of the best drugs for children with schizophrenia. But the fear remains The paperwork was never really the problem with clozapine
https://www.statnews.com/2026/09/04/clozapine-children-schizophrenia-neutrophil-fda-monitoring/
By Nitin GogtaySept. 4, 2026
Gogtay is a psychiatrist, physician-scientist, and author of “The Vanishing Children: A Psychiatrist’s Journey to Unravel the Mysteries of Childhood Psychosis.”
Recipients of gene-edited pig kidneys successfully receive human organs Pair of cases mark a milestone for eGenesis in effort to advance xenografts
https://www.statnews.com/2026/09/03/recipients-of-gene-edited-pig-kidneys-receive-human-organs/
By Eric BoodmanSept. 3, 2026
General Assignment Reporter
‘Tactical athletes’ get new guidance for cardiovascular fitness Military, emergency response, and public safety personnel face increased risk — and responsibility for others
https://www.statnews.com/2026/09/03/tactical-athlete-health-risks-new-cardiovascular-guidelines-police-firefighters/
By Elizabeth CooneySept. 3, 2026
Cardiovascular Disease Reporter
Make infectious disease data boring again The CDC’s fight with Pennsylvania over what counts as a measles death is high drama — and deeply disturbing
https://www.statnews.com/2026/09/04/pennsylvania-measles-deaths-data-cdc-director-rfk-jr/
By Debra Houry and Demetre DaskalakisSept. 4, 2026
Houry is the former CDC chief medical officer. Daskalakis is the former director of the CDC’s National Center for Immunization and Respiratory Diseases.
Lindsay Clancy case exposes dangers of fragmented U.S. health system, experts say Clancy’s defense attorney has blamed the clinicians who treated her for failing in their duties
https://www.statnews.com/2026/09/04/lindsay-clancy-health-care-silos-postpartum-care-failures/
By Tara BannowSept. 4, 2026
Hospitals and Insurance Reporter
Offline: How to save WHO Richard Horton + +...
Offline: How to save WHO
Richard Horton
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01805-2/fulltext?dgcid=raven_jbs_etoc_feature_lancet
Sep 05, 2026
Volume 408Number 10558p867-968, e4-e9
https://www.thelancet.com/journals/lancet/issue/vol408no10558/PIIS0140-6736(26)X2033-5
Advancing Real-World Evidence Program
https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program?utm_medium=email&utm_source=govdelivery#:~:text=As%20announced%20in%20the%20Federal%2cnew%20indications%20of%20approved%20medical
The deadline for the eighth submission cycle of the U.S. Food and Drug Administration’s Advancing Real-World Evidence (RWE) Program is September 30, 2026.
Of note, FDA has also updated the frequently asked questions section of the Advancing RWE Program website.
For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in CDER, CBER, and OCE, before protocol development or study initiation, to discuss the use of RWE in medical product development.
The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage the agency will continue to be available.
For more information on the program, visit the Advancing Real-World Evidence Program webpage.
Advancing Real-World Evidence Program Frequently Asked Questions
https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program-frequently-asked-questions?utm_medium=email&utm_source=govdelivery
HPM Presenting at IQVIA Annual Controlled Substances & State Regulatory Conference (Sept. 16-18) September 4, 2026
https://www.thefdalawblog.com/2026/09/hpm-presenting-at-iqvia-annual-controlled-substances-state-regulatory-conference-sept-16-18/?utm_source=rss&utm_medium=rss&utm_campaign=hpm-presenting-at-iqvia-annual-controlled-substances-state-regulatory-conference-sept-16-18
Hyman, Phelps & McNamara, P.C.’s Karla Palmer and Andrew Hull will be speaking again at IQVIA’s 28th Annual Controlled Substance & State Regulatory Conference in Scottsdale, AZ (Sept. 16-18). As part of a stacked agenda that runs the gamut on controlled substances issues, Ms. Palmer will speak on compliance considerations for compounders, and Mr. Hull will present on how registrants can mitigate risk and preserve reputation during a DEA investigation. Mr. Hull will also be presenting a course with retired DEA Chief Administrative Law Judge John J. Mulrooney, II, a partner at Belanger Rae & Mulrooney, on protecting your rights in DEA administrative actions.
jueves, 3 de septiembre de 2026
Alcohol-linked cancer deaths doubled over three decades in America
https://www.news-medical.net/news/20260902/Alcohol-linked-cancer-deaths-doubled-over-three-decades-in-America.aspx
Alcohol-attributable cancer deaths in the U.S. doubled between 1990 and 2023, a new study found. The study also revealed that alcohol-linked cancer deaths are not limited to older adults or liver cancer. Among adults ages 20 to 54, colorectal cancer was the leading alcohol-attributable cancer death in men, while breast cancer ranked first in women. The study also showed a growing burden from colorectal, esophageal, pancreatic and other cancers.
Immigrants face longer ICU stays after stroke in Canada
Among people who have a stroke in Canada, immigrants were admitted to the intensive care unit (ICU) at similar rates as long-term residents or people who were born in Canada, but they were more likely to have longer stays in the ICU, according to a study published September 2, 2026, in Neurology®, the medical journal of the American Academy of Neurology.
https://www.news-medical.net/news/20260902/Immigrants-face-longer-ICU-stays-after-stroke-in-Canada.aspx
Innovation vs. regulation? AI is revolutionizing biotechnology—but raising unintended risks and ethical concerns Chelsea Francek | September 2, 2026
https://geneticliteracyproject.org/2026/09/02/innovation-vs-regulation-ai-is-revolutionizing-biotechnology-but-raising-unintended-risks-and-ethical-concerns/
The recent announcement of novel, viable viruses created by artificial intelligence (AI) was celebrated as a major advance in the fight against antibiotic resistance. But it also raised urgent concerns about regulation.
Fact vs misinformation: An official EU guide to GMOs and gene-edited foods European Parliament | September 1, 2026
https://geneticliteracyproject.org/2026/09/01/fact-vs-misinformation-an-official-eu-guide-to-gmos-and-gene-edited-foods/
The rules governing new gene editing techniques for plants – called “new genomic techniques” (NGTs) – are being changed at EU level. Gene-edited plants will be divided into two categories, depending on the type and number of edits involved. Those with few genetic changes that could have occurred through conventional breeding techniques will be considered conventional plants, while the rest will have to follow the same strict rules as GMOs.
Viewpoint: Realpolitik environmentalism is on the horizon David Zaruk | September 3, 2026
https://geneticliteracyproject.org/2026/09/03/viewpoint-realpolitik-environmentalism-is-on-the-horizon/
When was the last time you heard someone call themselves an “environmentalist”?
A decade ago, self-professed environmentalists would proudly claim to all in earshot that they cared for the environment, that they lived sustainably and answered to a higher calling as agents of change to make Mother Earth whole again. These martyrs for the cause identified themselves by their green choices and eagerly displayed their badges and totems. The implication, a decade ago, was that the rest of us were heathens, polluters and peasants.
Science Literacy Project Daily Digest Science Controversies in the Media ++++ ++++
Science Literacy Project Daily Digest
Science Controversies in the Media
How climate change could impact food safety
Popular Mechanics
https://geneticliteracyproject.org/2026/09/03/how-climate-change-could-impact-food-safety/
Climate change isn’t just fueling stronger storms and longer droughts — it’s also making the food on your plate riskier, as Popular Mechanics’ Darren Orf reports. A new review from researchers at Ethiopia’s Public Health Institute and Dambi Dollo University, published in the study in One Health Outlook, found that rising temperatures, shifting rainfall, and extreme weather are accelerating the spread of foodborne pathogens worldwide.
Do-it-yourself, anti-aging wonder drug deception: No evidence yet metformin works
Nautilus
https://geneticliteracyproject.org/2026/09/03/do-it-yourself-anti-aging-wonder-drug-deception-no-evidence-yet-metformin-works/
Biohackers have long touted metformin, a cheap diabetes drug, as a secret weapon against aging. But a new review finds the evidence doesn’t yet back the hype, as Nautilus’s Jake Currie reports.
Viewpoint: If Trump has his way, nitrogen oxide-polluting AI data centers will be exempt from air pollution rules
The Guardian
https://geneticliteracyproject.org/2026/09/03/viewpoint-if-trump-has-his-way-nitrogen-oxide-polluting-ai-data-centers-will-be-exempt-from-air-pollution-rules/
The Trump administration is moving to end public notification of air pollution from AI data centers, as Guardian reporter Tom Perkins reports. A proposed EPA rule would make it optional, rather than required, for developers to disclose how much nitrogen oxide, carbon monoxide, and other pollutants their generators and turbines will release under so-called “minor source” Clean Air Act permits.
Death of a Chinese girl in a gene-editing trial raises concerns about China’s rush to become a biomedical superpower
Science
https://geneticliteracyproject.org/2026/09/03/death-of-a-chinese-girl-in-a-gene-editing-trial-raises-concerns-about-chinas-rush-to-become-a-biomedical-superpower/
Six-year-old “Mei” had Snijders Blok-Campeau syndrome, a disorder diagnosed in just 237 people worldwide, marked by developmental delays and simple speech. In March 2025, doctors at Shanghai’s Xinhua Hospital infused trillions of viruses carrying an experimental base-editing therapy into her spinal fluid to correct the mutation. Seven days later she died of a severe immune reaction — a death never made public, as Science and Retraction Watch reveal in a joint investigation by Brendan Borrell.
Deadly ‘faith healing’ exemption: Idaho remains the only state shielding parents from prosecution for replacing medical care with prayer or spirits—even if their child dies
Audrey Dutton | ProPublica
https://geneticliteracyproject.org/2026/09/02/deadly-faith-healing-exemption-idaho-remains-the-only-state-shielding-parents-from-prosecution-for-replacing-medical-care-with-prayer-or-spirits-even-if-their-child-dies/
In Idaho, parents who say their faith prohibits lifesaving medical care for their children can’t be charged with child neglect or manslaughter. Supporters of this protection over the years have included lawmakers who voiced support for “traditional” Idaho values.
Viewpoint: With Trump’s declining mental health and an incapacitated Mitch McConnell unlikely to return to the Senate, America’s gerontocracy needs a Public Physician
The Atlantic
https://geneticliteracyproject.org/2026/09/02/viewpoint-with-trumps-declining-mental-health-and-an-incapacitated-mitch-mcconnell-unlikely-to-return-to-the-senate-americas-gerontocracy-needs-a-public-physician/
Senator Mitch McConnell, 84, hasn’t spoken publicly since an ambulance took him from his Washington home on June 14th, 2026. In The Atlantic, geriatrician Rachael Bedard argues his opaque absence exposes a real gap in American government: no independent body checks whether aging officials are still fit to serve.
Viewpoint: RFK Jr. and other vaccine denialists blame vaccines for a surge in severe autism. The surge is a myth—and here’s why
Quillette
https://geneticliteracyproject.org/2026/09/02/viewpoint-rfk-jr-and-other-vaccine-denialists-blame-vaccines-for-a-surge-in-severe-autism-the-surge-is-a-myth-and-heres-why/
Donald Trump and Robert F. Kennedy Jr. keep pointing to what they call an explosion of severe autism cases as proof that vaccines are poisoning American children, but the epidemiology doesn’t support the claim, as epidemiologist Geoffrey C. Kabat argues in Quillette. Trump has claimed that “large amounts of vaccine, large amounts of like vats of vaccine are currently pumped into your child’s body,” insisting rates were far lower when children received fewer shots. Kabat’s rebuttal: what has actually ballooned is the diagnosis, not the disorder.
Can cloud seeding ease the deepening drought across the American West?
New York Times
https://geneticliteracyproject.org/2026/09/02/can-cloud-seeding-ease-the-deepening-drought-across-the-american-west/
A 26-foot tower resembling a football goalpost in Moab, Utah, pulses electrical charges into clouds — and its maker says that boosted snowfall in the La Sal Mountains 15 percent last winter, as Scott Dance reports for The New York Times. The claim, from Rain Enhancement Technologies, reflects a bigger Western bet: drought-stricken states, utilities and ski resorts are pouring millions into cloud seeding for more rain and snow.
Zero: That is the official American measles death toll for 2026. Here is what RFK Jr.’s CDC leaves out. Henry Miller | September 3, 2026
https://geneticliteracyproject.org/2026/09/03/zero-that-is-the-official-american-measles-death-toll-for-2026-here-is-what-rfk-jr-s-cdc-leaves-out/
The Centers for Disease Control’s weekly measles report is supposed to be a scientific record, not an opportunity to score political points. But this is the Trump administration, where everything, sadly, including science and health policy, appears to be driven by self-interest, personal grievances, and ideological litmus tests. Why should the current uproar over two measles-related deaths in Pennsylvania last month be any different?
Med Students’ Secret Weapon? Sleep Kelly K. James
https://www.medscape.com/viewarticle/med-students-secret-weapon-sleep-2026a1000wnl
Every doctor knows that medical school and residency are incredibly demanding. “From a medical student standpoint, not only is there classwork during the day but so much at night to prep for — what you’ve learned and what you’re going to learn,” said Eric J. Olson, MD, p rofessor of medicine at the Mayo Clinic Alix School of Medicine in Rochester, Minnesota, and a pulmonologist and sleep medicine specialist.
Rheumatologists Seek Changes to Looming Medicaid Work Rules Kerry Dooley Young
https://www.medscape.com/viewarticle/rheumatologists-seek-changes-looming-medicaid-work-rules-2026a1000wnr
A new Medicaid rule could unfairly cost people with rheumatologic diseases their access to healthcare, while also creating unnecessary administrative burdens for clinicians, medical groups said.
At issue are standards for judging medical exemptions set in an interim final rule that the Centers for Medicare & Medicaid Services (CMS) published in June.
Steady and Strategic: Medscape Hospitalist Wealth & Debt Report 2026 Tony Stasiek
https://www.medscape.com/p11/steady-and-strategic-medscape-hospitalist-wealth-debt-report-2026a1000tgd
Since we last checked in with hospitalists in the 2024 Medscape Hospitalist Wealth & Debt Report, their financial picture has remained relatively consistent.
Call it an offshoot of hospitalists' "balanced lifestyle," says Lawrence B. Keller, CFP, founder of Physician Financial Services in Melville, New York.
"Hospitalists know that, for the most part, they are not going to be earning what a surgeon or a proceduralist is going to earn," says Keller, whose firm has nearly 5000 physician clients across the United States. "So they're very much attuned to their financial planning, their finances, and their financial goals -- probably more than some other specialists."
I was a doula before I was an OB-GYN. I wish the two professions understood each other more At a difficult birth, the doula in me understood the disappointment. The doctor in me understood the urgency
https://www.statnews.com/2026/09/03/doula-turned-ob-gyn-birth-plan-disappointment-urgency/
By Debra EluobajuSept. 3, 2026
Eluobaju is a maternal-fetal medicine fellow at Weill Cornell Medicine.
FDA pilot offers generative AI medical devices a path to patients before they are authorized TEMPO program offers regulators hands-on experience with cutting edge tech in real-world settings
https://www.statnews.com/2026/09/03/tempo-fda-pilor-generative-ai-medical-device-regulation/
By Mario AguilarSept. 3, 2026
Health Tech Correspondent
A surprising bright spot at the FDA on regulating unproven stem cells Two recent actions show that the FDA’s biologics branch continues to take action
https://www.statnews.com/2026/09/03/stem-cell-clinics-fda-cber-warning-letters-marketing/
By Paul KnoepflerSept. 3, 2026
Knoepfler is a professor of cell biology and human anatomy at UC Davis School of Medicine.
The pediatricians who take in vaccine-skeptical parents others won’t By Eric BoodmanSept. 3, 2026
The pediatricians who take in vaccine-skeptical parents others won’t
At a ‘practice of last resort,’ doctors prioritize allaying concerns without hardline dismissals
By Eric BoodmanSept. 3, 2026
In his reporting on the fallout from federal messaging on vaccines, Boodman interviewed nine pediatricians in six states and spent a day shadowing Aaron Bornstein during a meet-and-greet with a vaccine-hesitant parent.
https://www.statnews.com/2026/09/03/vaccine-hesitant-parents-how-pediatrician-builds-trust/
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling September 2026
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-hepatic-function-study-design-data-analysis-and-impact-dosing-and?utm_medium=email&utm_source=govdelivery
FDA Publishes Draft Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance entitled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This draft guidance replaces the May 2003 guidance entitled “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling,” and when finalized, will represent FDA’s current thinking.
Liver disease can lead to changes in a drug’s pharmacokinetics to a degree necessitating different recommendations for use of the drug in patients with hepatic impairment. This draft guidance is intended to provide recommendations to sponsors and applicants who plan to conduct studies to assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, pharmacodynamics of a drug, including therapeutic biological products.
FDA seeks feedback on this draft guidance document. To ensure the FDA considers your comment, please submit your comments by Dec 1, 2026, at 11:59 PM EST to the docket (Docket No. FDA-2026-D-8693).
https://www.regulations.gov/docket/FDA-2026-D-8693?utm_medium=email&utm_source=govdelivery
Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research
https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard?utm_medium=email&utm_source=govdelivery
FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research
For decades, Good Clinical Practice (GCP) has provided the ethical and scientific foundation for clinical investigations submitted to the U.S. Food and Drug Administration. Its purpose is straightforward: establishing a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that helps ensure that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. All clinical trials of investigational products submitted to the FDA must comply with GCP.
Today, this foundation is being tested by the scale and globalization of modern clinical research. While there are various benefits to this global expansion, it is also introducing new risks to oversight, transparency, and data integrity. Multi-regional trials without an American patient at all or with only a small percentage of patients in the United States present a variety of concerns for American patients, for the FDA, and, increasingly, for policymakers in Congress. Trials that fail to enroll American patients can be less easily generalized to the population the products are intended to treat. It also means Americans are losing out on the opportunity to participate in trials of innovative or breakthrough medical products.
Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI September 3, 2026 By Adrienne R. Lenz, Principal Medical Device Regulation Expert —
https://www.thefdalawblog.com/2026/09/regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai/?utm_source=rss&utm_medium=rss&utm_campaign=regulating-a-moving-target-fda-seeks-comments-on-possible-framework-for-regulation-of-genai
On August 18, 2026, FDA’s Center for Devices and Radiological Health (CDRH) released Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (Discussion Paper). The paper is not draft or final guidance; rather, it is intended to solicit feedback on the regulation of generative artificial intelligence (GenAI)-enabled medical devices. It poses 26 discussion questions in the categories of assessment of risk, a competency-based approach for premarket evaluation, postmarket monitoring, foundation model device master files, and considerations for agentic AI systems.
miércoles, 2 de septiembre de 2026
Alcohol-related liver cancer deaths were falling. Then the trend reversed during the COVID-19 pandemic Download PDF Copy
While deaths from several alcohol-attributable conditions have fallen globally, one cancer followed a strikingly different trajectory during the pandemic years.
https://www.news-medical.net/news/20260901/Alcohol-related-liver-cancer-deaths-were-falling-Then-the-trend-reversed-during-the-COVID-19-pandemic.aspx
In a recent study published in the journal npj Science of Food, researchers used data from the Global Burden of Disease (GBD) 2023 study to investigate global, regional, and national trends in alcohol-attributable mortality from four specific conditions (1990 to 2023). The study evaluated these mortality patterns across 204 countries and territories. It further assessed temporal shifts in alcohol-attributable mortality trends coinciding with the COVID-19 pandemic. Finally, trend data were modeled to estimate future alcohol-attributable mortality rates through 2050.
Radiologist supply fails to keep pace with rising imaging demand
https://www.news-medical.net/news/20260902/Radiologist-supply-fails-to-keep-pace-with-rising-imaging-demand.aspx
Demand for medical imaging in the U.S. keeps rising, but the number of radiologists available to read those images has barely budged relative to the population, according to a new research study published in the JACR®.
From navigating a system that was not built for people with rare diseases, to working to change that system from both sides
https://rarerevolutionmagazine.com/from-navigating-a-system-that-was-not-built-for-people-with-rare-diseases-to-working-to-change-that-system-from-both-sides/
From overcoming daily physical and societal hurdles in the classroom to facing misconceptions within the medical community, Sarah Mullahy shares her personal journey of advocacy and her path toward becoming a doctor dedicated to patient-centered care.
Written by Sarah Mullahy
In 2003, after a short stay in the neonatal intensive care unit, I was discharged home, only to be readmitted months later with failure to thrive. An atrial septal defect was found during that admission. When I was still very young my family moved to South Africa for a year. It was a specialist there who looked at the wider picture and insisted we see a geneticist once we returned to Ireland. I was diagnosed clinically with Noonan syndrome in 2005, at the age of two. In 2008, when genetic testing became more available, an alteration in the PTPN11 gene confirmed what the clinicians had already recognised.
UnitedHealthcare to Drop Prior Authorization Requirements for Range Of Conditions From Oct. 1
https://www.medscape.com/s/viewarticle/unitedhealthcare-drop-prior-authorization-requirements-range-2026a1000vfv
Sept 1 (Reuters) - UnitedHealth's insurance unit said on Tuesday that a broad range of conditions will no longer need prior approval, effective October 1, as it aims to eliminate prior authorization for 30% of healthcare services by the end of this year.
Oncology Firm Novocure Says Cyberattack Exposed US Patient Records
https://www.medscape.com/s/viewarticle/oncology-firm-novocure-says-cyberattack-exposed-us-patient-2026a1000vrc
Sept 1 (Reuters) - Oncology company Novocure said on Tuesday a cybersecurity incident involving unauthorized access to certain information systems in mid-August exposed internal records of more than 1,400 U.S. patients.
Reviewing and Negotiating Contracts After Residency Aerial Petty, DO; Jane Simpson, DO
https://www.medscape.com/viewarticle/reviewing-and-negotiating-contracts-after-residency-2026a1000u8l
Aerial Petty, DO: My name is Aerial Petty. I am a family physician and the outgoing Resident Member to the Board of the American Academy of Family Physicians (AAFP). I graduated from my residency program at NewYork-Presbyterian/Columbia University Irving Medical Center in New York city, and then recently completed the Family Medicine CPV-GW Health Policy Research Fellowship in Washington, DC. I’m in a new physician in practice.
Fiscal Year 2027 NIH HIV/AIDS Professional Judgment Budget
https://oar.nih.gov/sites/g/files/mnhszr366/files/OAR_FY_27_PJ_FINAL_508.pdf?j=3055719&sfmc_sub=6992026&l=6498_HTML&u=76636337&mid=100006181&jb=0
The NIH Office of AIDS Research (OAR) has released the Fiscal Year 2027 NIH HIV/AIDS Professional Judgment Budget.
Each year, as required by the NIH Revitalization Act of 1993, OAR prepares the NIH HIV/AIDS Professional Judgment Budget (PJ) for submission to the President and Congress. The PJ highlights opportunities for further investment in HIV research, and estimates resources needed to fully fund HIV research, beyond the President’s budget, without expectation of receiving that funding.
https://oar.nih.gov/hiv-policy-and-research/budget/fiscal-year-2027-nih-hivaids-professional-judgment-budget
The FY 2027 NIH HIV/AIDS PJ highlights five areas where recent findings show exciting potential to advance the health of people affected by HIV. The highlighted areas cut across the research continuum.
• Accelerate implementation science to end the HIV epidemic
• Develop new technologies for self-testing and multiplex testing
• Understand and treat HIV-related co-occurring conditions
• Advance progress towards an HIV cure
• Strengthen HIV data sharing and harmonization
OAR estimates the additional funding for expanded NIH HIV research at $1.059 billion, or 32 percent, over the FY 2026 enacted budget of $3.294 billion.
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory, and Submission Updates Tuesday, September 29, 2026
https://www.fda.gov/media/193623/download?utm_medium=email&utm_source=govdelivery
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates
September 29, 2026
https://www.fda.gov/drugs/news-events-human-drugs/fdas-drug-registration-and-listing-workshop-compliance-regulatory-and-submission-updates-09292026?utm_medium=email&utm_source=govdelivery
Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates
September 29, 2026 | 8:45 a.m. - 4:00 p.m. ET
In-Person or Virtual
Join SBIA as the FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes. We'll also dive into compliance strategies for drug amount reporting requirements — a great opportunity to ask questions and hear directly from those working at the forefront of these issues.
Pharmalittle: We’re reading about a Huntington’s gene therapy, Novo’s challenges, and more New White House drug pricing deals might not amount to much, at least not immediately
https://www.statnews.com/pharmalot/2026/09/02/uniqure-huntingtons-fda-novo-nordisk-investors-pharmalittle-newsletter/
By Andrew JosephSept. 2, 2026
Europe Correspondent
The next DSM should address the algorithm’s role in eating disorders Clinicians already screen for trauma and family history. Digital exposure should be part of that
https://www.statnews.com/2026/09/02/dsm-6-eating-disorders-algorithms-social-media-influence-screening/
By Jessica Scheer and Riley NickolsSept. 2, 2026
Scheer is CEO of the National Eating Disorders Association. Nickols is a sports psychologist and clinical adviser for the NEDA.
I’m a reproductive psychiatrist. The Lindsay Clancy trial will cause terrible damage to my field Rather than prompting a renaissance in treating postpartum mental illness, the trial will make things worse
https://www.statnews.com/2026/09/01/lindsay-clancy-trial-verdict-postpartum-psychosis-psychiatry/
By Jennifer Adaeze OkwerekwuSept. 1, 2026
Okwerekwu is a reproductive psychiatrist in private practice.
How Trump’s latest pharma deals may undermine efforts to rein in drug costs In agreeing to lower prices in Medicaid, drugmakers are exempt from lowering prices in Medicare
https://www.statnews.com/2026/09/02/trump-most-favored-nation-drug-pricing-industry-analysts-skeptical/
By John WilkersonSept. 2, 2026
Washington Correspondent
Diabetes association CEO: What an independent review says happened at the ADA’s controversial June conference And how we can move forward
https://www.statnews.com/2026/09/01/american-diabetes-association-june-conference-independent-review/
By Charles "Chuck" HendersonSept. 1, 2026
Henderson is the CEO of the American Diabetes Association.
Suscribirse a:
Entradas (Atom)

