miércoles, 31 de diciembre de 2025
Catheter-Associated Urinary Tract Infections (CAUTI)
https://safetyprogram4hai-prevention.ahrq.gov/page/home
AHRQ Safety Program for HAI Prevention: CAUTI Informational Webinar
January 13, 3–3:30 p.m. ET
January 22, 2–2:30 p.m. ET
Introducing the CAHPS End-of-Life Care Survey (Webcast) Date: Thursday, January 15, 2026 Time: 1:00–2:00 PM ET
https://www.ahrq.gov/cahps/news-and-events/events/webinar-end-of-life-survey-011526.html
January 15, 1–2 p.m. ET: CAHPS End-of-Life Care Survey Webcast
Join AHRQ EPC Grand Rounds session Jan. 20 on Workplace Safety and Well-Being
https://effectivehealthcare.ahrq.gov/news/jan-2026-grand-rounds
January 20, 1–3 p.m. ET: AHRQ Evidence-based Practice Center Program Grand Rounds session on Workplace Safety and Well-Being
AHRQ Stats: Prevalence of Chronic Conditions or Obesity in Geographic Regions
AHRQ Stats: Prevalence of Chronic Conditions or Obesity in Geographic Regions
The prevalence of adult obesity or chronic condition diagnoses varied by region in 2022, ranging from 72.4 percent in the West to between 77.2 percent and 79.2 percent in other regions. Of adults not living in a Metropolitan Statistical Area, 85.2 percent had a diagnosis compared with 76 percent of those living in a Metropolitan Statistical Area. (Source: AHRQ Medical Expenditure Panel Survey Research Findings #52, Combined Prevalence of Chronic Conditions or Obesity for Adults in 2022.)
https://meps.ahrq.gov/mepsweb/data_stats/Pub_ProdResults_Details.jsp?pt=Research%20Findings&opt=2&id=1320
Triptans May Be Offered to Well-Informed Pregnant Women With Migraines
https://pubmed.ncbi.nlm.nih.gov/40719668/
An AHRQ-funded study found that using triptans—medications for migraine relief—during pregnancy did not lead to higher risks of birth complications. Researchers analyzed data from over two decades for more than 3,800 pregnant women with migraines and found no major differences in outcomes like preterm birth, cesarean delivery, or birth defects between those who used triptans and those who did not. Importantly, the triptan group reported no cases of miscarriage, ectopic pregnancy, or hypertensive disorders like preeclampsia. These results suggest that triptans, especially sumatriptan, may be a safe option for pregnant women who need medication to manage severe migraines. Access the abstract in Mayo Clinic Proceedings.
Algorithm Enhances Identification of Tobacco Use Among Veterans
https://www.sciencedirect.com/science/article/pii/S1047279725002558?via%3Dihub
A new algorithm, developed through an AHRQ-funded study, identifies tobacco use among veterans using electronic health record (EHR) data. Tobacco use remains a leading cause of death in the United States, yet it can be hard to track in EHRs because information is scattered across multiple data sources. Researchers created a rules-based algorithm using data from the Veterans Affairs Corporate Data Warehouse, including health factors, diagnosis codes, medication orders, billing, and encounter information. They then validated the algorithm’s accuracy against 429 manually reviewed EHR charts and a national self-report survey. The algorithm, which will be available for Veterans Health Administration researchers, could improve identification of veterans with a history of tobacco use, helping target prevention, screening, and future research on tobacco-related health risks. Read the full article in Annals of Epidemiology.
No Evidence That Non-Antibiotic Medications Reduce Symptoms of Lower Respiratory Tract Infections
https://pubmed.ncbi.nlm.nih.gov/40681786/
Medications such as corticosteroids, anti-cough medication, and inhalers are not associated with the duration or severity of illness for adult outpatients with lower respiratory tract infections (LRTI), according to an AHRQ-funded study published in the Journal of General Internal Medicine. The authors examined the use and effectiveness of non-antibiotic alternatives in patients with LRTI because physicians frequently prescribe them to avoid risks of microbial resistance, but there are few studies on their impact. The team enrolled 718 primary and urgent care patients with acute LRTI and followed them for up to 28 days to study symptom progressions. They found no association between receiving a corticosteroid, a short-action inhaler, or benzonatate (a cough suppressant) with the duration or severity of cough or the need for an unscheduled followup visit. The authors suggested that use of these non-antibiotic medications is inappropriate and carries real risks for patients.
Federal Support Strengthens Primary Care Practices and Outcomes
https://jamanetwork.com/journals/jama-health-forum/fullarticle/2840801
A systematic review in JAMA Health Forum, written collaboratively by AHRQ and Centers for Medicare & Medicaid Services staff, found that federal investments in primary care resulted in better access to needed services, reduced acute care utilization, and increases in care that physicians and practices rate as high quality. The study examined 142 records from 5 federal programs over the course of 10 years (2011–2021): the Federally Qualified Health Center Advanced Primary Care Practice demonstration, the Multi-Payer Advanced Primary Care Practice model, the Comprehensive Primary Care (CPC) initiative, CPC Plus, and AHRQ’s EvidenceNOW Advancing Heart Health. Program implementation led to greater patient engagement, much improved care delivery, modest utilization reductions, and net increases in expenditures. Researchers also found that barriers to program implementation included funding limitations, difficulties with electronic health records and payer data, and practice staff turnover. Access the study for more details.
AHRQ Safety Program for HAI Prevention: Webinars Highlight CAUTI Program Resources and Recruitment Details: Recording Available
https://safetyprogram4hai-prevention.ahrq.gov/page/home
In December, the AHRQ Safety Program for Healthcare-Associated Infection (HAI) Prevention hosted two informational recruitment webinars for hospitals interested in joining the cohort focused on preventing catheter-associated urinary tract infections (CAUTI). The December 2 and December 11 sessions— featuring lead subject matter experts Sara Keller, M. D., M.P.H., M.S.P.H., and Valeria Fabre, M.D.—included Q&A discussions addressing participant questions. Speakers highlighted that the program will offer resources for diagnostic stewardship, including materials and a webinar focused on urine cultures and urinalysis. In addition, presenters outlined data collection support, including tools, checklists, and a collection guide outlining all requirements. Don’t miss the final two informational webinars on January 13 and January 22. Visit the website to register, or download presentation materials to learn more about participation benefits including expert coaching, implementation support, and free CME/CEU credits. Act now and apply for the program before the January 30, 2026, deadline. Recruitment is open to all states. The program is especially interested in participants representing the Midwest, Northeast, and Northwest.
CMS Releases Guidance on 2027 Updates to the Child and Adult Core Health Care Quality Measurement Sets and Mandatory Reporting
https://www.medicaid.gov/federal-policy-guidance/downloads/sho25005.pdf
Today, the Centers for Medicare & Medicaid Services (CMS) released a State Health Official (SHO) Letter that describes the 2027 updates to the core set of children’s health care quality measures for Medicaid and the Children’s Health Insurance Program (CHIP) (Child Core Set) and the core set of health care quality measures for adults enrolled in Medicaid (Adult Core Set). The letter includes guidance to states specific to 2027 mandatory reporting of the Child Core Set and the behavioral health measures on the Adult Core Set. This letter also includes updates to the 2026 Core Sets.
https://www.medicaid.gov/medicaid/quality-of-care/performance-measurement/adult-and-child-health-care-quality-measures
martes, 30 de diciembre de 2025
Introducing the CAHPS End-of-Life Care Survey Webcast January 15, 2026 1:00 PM - 2:00 PM EST
https://cma.ahrq.gov/cma/welcome.jsp?code=CAHPS_End_of_Life_Care_Survey
Please note that this webcast has been rescheduled from its original date of October 16, 2025. Registrations from those who signed up previously are still valid and active.
Register for this free, one-hour webcast introducing AHRQ’s new Consumer Assessment of Healthcare Providers and Systems (CAHPS®) End-of-Life Care Survey. Join leading experts as they discuss why the survey was developed, how it was tested, and best practices for successful implementation. Kaiser Permanente will share lessons learned from field testing the survey in their end-of-life care programs.
Speakers:
Jonathan Bakdash, Ph.D., Agency for Healthcare Research and Quality
Rebecca Anhang-Price, Ph.D., RAND
Melissa Bradley, RAND
Susan Wang, MD, Kaiser Permanente
Stephanie Fry, CPXP, (Moderator), Westat
For questions, please contact the CAHPS User Network at cahps1@westat.com or 1-800-492-9261.
Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics
https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics?utm_medium=email&utm_source=govdelivery
December 29, 2025
Today, the U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. While the report reviews available scientific evidence on potential safety concerns, the FDA’s evaluation did not reach definitive safety determinations and underscores significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics.
Based on mandatory cosmetic product listing data submitted to the FDA, 51 PFAS are used in 1,744 cosmetic formulations. To assess safety, the FDA evaluated the 25 most frequently used PFAS, which represent approximately 96% of PFAS intentionally added to cosmetic products. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” limiting its ability to fully assess risk. The FDA’s ability to effectively collect toxicology data was limited by the fact that most of the data is not publicly available. While five PFAS appeared to present low safety concerns under their intended conditions of use, the safety of most PFAS could not be definitively established, and one PFAS was identified as having a potential safety concern with significant remaining uncertainty.
The report focuses on PFAS intentionally added to cosmetic products as ingredients, rather than PFAS that may be present as contaminants. PFAS are synthetic chemicals used for properties such as water resistance, durability, and texture modification, but their persistence and potential toxicity have raised health and environmental concerns and prompted increasing regulatory scrutiny at the state, federal, and global levels.
There are currently no federal regulations that specifically prohibit PFAS intentionally added to cosmetic products. However, consistent with FDA enforcement policies, the agency will take appropriate action if safety concerns emerge related to such cosmetic products.
The FDA will continue to monitor emerging scientific data and devote additional resources to address data gaps, supporting the Department of Health and Human Services’ Make America Healthy Again efforts to reduce PFAS across the food and consumer product supply chain through expanded testing, monitoring, and surveillance.
Director of NIH neurological disorders institute is ousted, adding to leadership churn Agency declines to reappoint Walter Koroshetz, who has led NINDS since 2015
https://www.statnews.com/2025/12/27/nih-neurological-disorders-stroke-institute-director-koroshetz-ousted/
By Jonathan WosenDec. 27, 2025
West Coast Biotech & Life Sciences Reporter
The complicated truth about urinary tract infections in the elderly Not every positive urinalysis result requires antibiotics
https://www.statnews.com/2025/12/29/urinary-tract-infections-urinalysis-accuracy-elderly-patients/
By Neil GaffinDec. 29, 2025
Gaffin is an infectious disease physician in New Jersey.
In 2026, Kennedy’s MAHA vision gets put to the test. Here are 3 issues to watch Policy change will hit GLP-1s, dietary guidelines, and rural health, but to what effect?
https://www.statnews.com/2025/12/29/chronic-disease-maha-issues-to-watch-2026/
By Elizabeth Cooney, Isabella Cueto, and Sarah ToddDec. 29, 2025
Patients are consulting AI. Doctors should, too Some medical schools and health systems are still training students for the past
https://www.statnews.com/2025/12/30/ai-patients-doctors-chatgpt-med-school-dartmouth-harvard/
By Angelo VolandesDec. 30, 2025
Volandes is a professor at Dartmouth’s Geisel School of Medicine, a clinician-investigator, and vice chair of research for the department of medicine at Dartmouth Health.
With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market Patients using insurance may not see savings with Novo’s pricing strategy
https://www.statnews.com/2025/12/29/wegovy-pill-price-novo-nordisk-strategy-weight-loss-drugs/
By Elaine ChenDec. 29, 2025
Elaine Chen, a national biotech reporter, is the co-author of The Readout, a newsletter about the business, science, and politics of biotech.
CMS divvies up first payments from $50B rural health fund, with an eye toward MAHA goals Not all states are getting equal payments from program meant to transform health care systems
https://www.statnews.com/2025/12/29/trump-rural-health-fund-rewards-maha-ideas/?utm_campaign=daily_recap&utm_medium=email&_hsenc=p2ANqtz-88lv8FA3AA5c62oiL6OitpckgZlzcbU_IYqUS5vs0v-L2E2vG0JiG_2VbcH3GNBN7vqOSRMp3ht5YhHDrQ-DhvyDixrA&_hsmi=396329209&utm_content=396329209&utm_source=hs_email
By Daniel PayneDec. 29, 2025
Washington Correspondent
Drug Trials Snapshot: RHAPSIDO - RHAPSIDO (remibrutinib)
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-rhapsido
RHAPSIDO is a kinase inhibitor that is approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1-antihistamine treatment.
lunes, 29 de diciembre de 2025
Which factors contribute to male infertility remaining undiagnosed before assisted reproduction (Medscape AI)
https://www.medscape.com/ai-search?query=Which%20factors%20contribute%20to%20male%20infertility%20remaining%20undiagnosed%20before%20assisted%20reproduction&ecd=wnl_tp10_daily_251228_MSCPEDIT_etid7991240&uac=148436CN&impID=7991240
Early evaluation often focuses on the female partner, and a combination of patient-, provider-, and system-level issues leads to persistent underdiagnosis of male infertility prior to assisted reproduction.
How should clinicians reassess early response to suzetrigine in acute pain (Medscape AI)
https://www.medscape.com/ai-search?query=How%20should%20clinicians%20reassess%20early%20response%20to%20suzetrigine%20in%20acute%20pain&ecd=wnl_tp10_daily_251226_MSCPEDIT_etid7988671&uac=148436CN&impID=7988671
Clinicians initiating suzetrigine for acute pain should perform an early reassessment within 48–72 hours of starting therapy to determine efficacy and guide further management.
Can a blood test distinguish pancreatitis from pancreatic ductal adenocarcinoma (Medscape AI)
Blood‐based metabolite signatures have demonstrated the ability to differentiate pancreatic ductal adenocarcinoma (PDAC) from chronic pancreatitis (CP) with high accuracy in multicenter cohorts.
https://www.medscape.com/ai-search?query=Can%20a%20blood%20test%20distinguish%20pancreatitis%20from%20pancreatic%20ductal%20adenocarcinoma&ecd=mkm_ret_251228_mscpmrk_gastro_best-of-the-year_etid7989111&uac=148436CN&impID=7989111
Drug Trials Snapshots: DAWNZERA - DAWNZERA (donidalorsen)
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-dawnzera
DAWNZERA is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
Drug Trials Snapshots: HERNEXEOS - HERNEXEOS (zongertinib)
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-hernexeos
HERNEXEOS is a prescription drug used to treat adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
domingo, 28 de diciembre de 2025
sábado, 27 de diciembre de 2025
A Nation of Caregivers: Past, Present, and Future Expectations of Caregiving
Effects of probiotic lactobacilli on inflammatory responses to Escherichia coli in pig intestinal cells José D. Uezen, Jieyuan Jiang, María H. Miranda, María C. Aristimuño Ficoseco, Chengbo Yang, María E. F. Nader-Macias, Graciela M. Vignolo, Charles Martin Nyachoti
https://www.academia.edu/journals/academia-biology/articles?source=journal-top-nav
Effects of probiotic lactobacilli on inflammatory responses to Escherichia coli in pig intestinal cells
José D. Uezen [1],
Jieyuan Jiang [2],
María H. Miranda [1],
María C. Aristimuño Ficoseco [1],
Chengbo Yang [2],
María E. F. Nader-Macias* [1],
Graciela M. Vignolo [1],
Charles Martin Nyachoti [2]
https://www.academia.edu/2837-4010/3/4/10.20935/AcadBiol7982
In the swine industry, the increased awareness of the in-feed use of antibiotics due to the emergence of resistant bacteria led to an intense search for alternative strategies. Thus, to support swine optimal growth performance and gut health, dietary supplementation with probiotics was promisingly used. Here, porcine intestinal cells (IPEC-J2) were used to investigate the potential of probiotics Limosilactobacillus (Lim.) reuteri CRL2222, Lactobacillus (L.) amylovorus CRL2225, and Lactobacillus (L.) johnsonii CRL2229 to modulate innate immune functions and the intestinal barrier against injuries and pro-inflammatory reactions induced by ETEC F4 infection. By using qPCR, IPEC-J2 cell pre-treatment with each probiotic strain showed a significantly attenuated expression level of pro-inflammatory cytokines TNF-α, IL-8, and IL-6 during ETEC F4-induced infection. The gene expression of TLR4-mediated upstream related genes of the NF-κB signaling pathway (MyD88, IRAK-1, TRAF-6, and TAK-1) was significantly inhibited by the probiotic strains, resulting in the attenuation of inflammatory response in IPEC-J2 infected cells. Moreover, it was also revealed that Lim. reuteri CRL2222 and L. johnsonii CRL2229 probiotics increased the expression of zonula occludens 1 and occludin in ETEC F4-infected IPEC-J2 cells, alleviating the injury of epithelial barrier function. Therefore, these probiotics might be able to reduce pro-inflammatory cytokines blocking the NF-κB pathway through TLR4/MyD88 signaling and to prevent IPEC-J2 cells damage by enhancing the expression of tight-junction proteins. These results provide useful information on potential probiotics for the prevention/improvement of intestinal diseases in piglets.
Roles of the NFI/CTF gene family in transcription and development: update 2025 Richard M. Gronostajski* [1]
https://www.academia.edu/2837-4010/3/4/10.20935/AcadBiol8079
This review is an update of the review entitled “Roles of the NFI/CTF gene family in transcription and development” published in Gene in 2000 (referred to hereafter as the 2000 Gene review). That review began with the sentence “The Nuclear Factor I (NFI) family of site-specific DNA-binding proteins (also known as CTF or CAAT box transcription factor) functions both in viral DNA replication and in the regulation of gene expression.”, which is as valid now as it was then. The subsequent focus of NFI research has been on the role of individual or multiple family members in gene expression during development, in various adult organ systems, and the effect of NFI mutations in human syndromes. Here we will cover post-2000 studies with an emphasis on the role of NFI genes in brain, skin, blood, skeletal muscle, and retinal development; recent studies on the effect of hemizygosity of NFI genes in human development; the role of NFI genes in cancer; and the recently described 3D structure of the NFIX DNA-binding domain.
Monitoring of Kappaphycus alvarezii: a case study in the municipality of Pitimbu–PB Vanessa Simões do Nascimento [1] , George Emmanuel Cavalcanti de Miranda [2] , Êmille Natane de Araújo Barbosa [2] , Henrique Bezerra dos Santos* [3]
https://www.academia.edu/2837-4010/3/4/10.20935/AcadBiol8005
The cultivation of marine algae, especially red macroalgae, has grown significantly in recent decades, becoming an important source of raw material for various commercial sectors. The species Kappaphycus alvarezii has been used in this context, but this introduction into natural areas can represent ecological risks. This study seeks to evaluate if there is evidence of natural colonization of Kappaphycus alvarezii on reefs near cultivation areas and if this activity affects local reef cover. Three sampling areas were analyzed: one with a history of cultivation of the species and two control areas, all belonging to the same reef complex in the municipality of Pitimbu, Paraíba. Data collection was realized by underwater images (photoquadrats), subsequently analyzed with the CoralNet system, complemented by manual species inventory. Analyses compared the total macroalgae cover and diversity between areas, using the Shannon index. The results showed no evidence of Kappaphycus alvarezii adhering to natural substrates or reproductive structures of the species. These findings indicate a low potential for ecological invasion, suggesting that algae cultivation can be viable under appropriate environmental management practices. However, the current legislation prohibiting cultivation in the Northeast region needs to be reviewed, considering the results obtained and the possibility of sustainable use of the species.
Revisiting concepts of mitochondrial transport and energy metabolism in health and cancer Salvatore Passarella* [1]
https://www.academia.edu/2837-4010/3/4/10.20935/AcadBiol8065
Although our understanding of mitochondrial processes has expanded substantially, the contributions of metabolite transport and energy metabolism to mitochondrial function in health and disease remain incompletely characterized. The transport and metabolism of key metabolites, including oxaloacetate, L-lactate and D-lactate, are mediated by distinct transporters and mitochondrial enzymes that together influence cellular bioenergetics in normal and neoplastic tissues. This review reassesses mechanistic aspects of mitochondrial shuttles, gluconeogenesis and the Cori cycle, the mitochondrial transport and oxidation of L-lactate, the Warburg effect, and the methylglyoxal pathway. Emphasis is placed on evidence supporting mitochondrial uptake and metabolism of oxaloacetate and lactate isomers and on the implications of these processes for redox balance, anaplerosis, and biosynthesis in cancer. I propose that a fuller integration of metabolite transport phenomena into models of cellular metabolism is necessary to refine current concepts of mitochondrial physiology and pathophysiology.
Bacterial pathogens in fish and aquaculture systems in Kenya Ivy J. Mutai* [1,2] , Barack Nyanswi [1] , Eric Omori Omwenga [3] , Auleria Ajiambo Apopo [4] , Irene Kokushubila Lweikiza [1] , Victor Irungu Mwangi [5,6] , Michael Mugo [7] , Felix Mwai [8] , Mary A. Opiyo [9] , Zipporah Gichana [10] , Justus Nyongesa Opondo [1] , Jael Apondi Obiero [1] , Tabitha Wangari Nyoike [1] , Joseph Mwangi [11] , Abraham Ochieng [1] , Atunga Nyachieo [1]
https://www.academia.edu/2837-4010/3/4/10.20935/AcadBiol8049
The rising global demand for high-quality animal protein has driven the rapid expansion of aquaculture, which is now responsible for 51% of global fish production. However, intensive fish farming has led to the emergence and spread of bacterial pathogens that threaten fish health and raise serious concerns for food safety and public health. Bacterial infections in aquaculture contribute to an estimated USD 6 billion in annual global economic losses. In Kenya, the burden is particularly acute, with bacterial diseases accounting for approximately 76.1% of aquaculture-related losses. This review consolidates the fragmented scientific literature on the most significant bacterial pathogens affecting food fish and culture systems in Kenya, aiming to inform strategies that enhance fish product safety and aquaculture resilience. A comprehensive literature search was conducted across five databases—ScienceDirect, African Journals Online, Google Scholar, Web of Science, and FAO’s Aquatic Animal Health Database. The review identifies key bacterial species, their clinical manifestations, regional distribution, and the fish species affected. By profiling these pathogens and their impacts, the review provides actionable insights for policymakers, researchers, and fish farmers. To mitigate disease burden and further spread, the review recommends implementing robust biosecurity measures, including equipment disinfection, cohort quarantine, pathogen-free diets, farmer training, and routine microbiological surveillance. These interventions are essential for limiting pathogen spread, improving fish health, and safeguarding consumer safety. Ultimately, this work supports broader goals of sustainable fisheries, poverty alleviation, and global food security through improved ecosystem management and public health protection.
Brain-computer implants are coming of age. Here are 3 trends to watch in 2026 Flexible electrodes, brain implants for mental health, and Chinese competition
https://www.statnews.com/2025/12/26/brain-computer-interface-technology-trends-2026/
By O. Rose BroderickDec. 26, 2025
Disability in Health Care Reporting Fellow
3 issues to watch in public health in 2026 If this past year was any indication, it’s time to buckle up again
https://www.statnews.com/2025/12/26/public-health-2026-issues-to-watch/
By Helen BranswellDec. 26, 2025
Infectious Diseases Correspondent
PubMed has competition from Germany. That’s a very good thing The whole world can’t lean on one country’s scientific library
https://www.statnews.com/2025/12/26/pubmed-zb-med-scientific-repository-livivo/?utm_campaign=daily_recap&utm_medium=email&_hsenc=p2ANqtz-9xUMKOGITeu9r1uELjaXSQWOPqTUDqLJH4yQqueVd1YOuYArfijL9pCI0mn0cFjPt_B8hPBttJaxuZn1UWYW8YR3Ivxw&_hsmi=396067334&utm_content=396067334&utm_source=hs_email
By Sara Rubinelli, Rebecca Ivic, Kenneth H. Rabin, Lawrence O. Gostin, and Scott C. RatzanDec. 26, 2025
Rubinelli is professor of health communication and vice-dean of health sciences at the faculty of health sciences and medicine of the University of Lucerne. Ivic is associate dean of research and professor, College of Communication & Information Sciences, the University of Alabama. Rabin is senior scholar, City University of New York, Graduate School of Public Health and Health Policy. Gostin is distinguished university professor and director of the WHO Center on Global Health Law, Georgetown University. Ratzan is distinguished lecturer, City University of New York, Graduate School of Public Health and Health Policy and the editor-in-chief of the Journal of Health Communication.
Ivermectin to reduce malaria transmission– safety and efficacy results from the BOHEMIA cluster randomized trial in Mozambique ++...
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00566-8/fulltext?dgcid=raven_jbs_etoc_feature_eclinm
Editorial
The future of prostate cancer screening
eClinicalMedicine
https://www.thelancet.com/journals/eclinm/issue/vol90nonull/PIIS2589-5370(25)X0011-0
Tiny lives, big failures: India's drug regulation crisis The Lancet Regional Health – Southeast Asia ++...
Introducing Academia Global and Public Health Matteo Charles Malvezzi* [1]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8010
It is my honor to welcome you, the reader and prospective contributor, to Academia Global and Public Health. In this inaugural editorial, I would like to outline the future aims and scope of this journal. But before doing so, let me underscore what we consider to be our highest priority: being an author-centered journal built for scientific readers and contributors. Our mission is to build a bond of trust with our authors and readers. To achieve this, we will strive for quality over quantity, selecting published material with care and ensuring that the peer review process is fair, timely, and constructive.
Noise pollution and public health curricula: a missing link in environmental health preparedness Francesco Aletta* [1]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8070
Environmental noise is a pervasive yet under-recognized public health hazard. Robust evidence links transport and community noise exposure to a range of adverse health outcomes, including sleep disturbance, cardiovascular disease, cognitive impairment, and reduced quality of life. Yet, despite its clear health burden, noise pollution remains marginal in global health agendas and is inconsistently integrated into education and training. Recent reforms to public health curricula, particularly in the United States, have contributed to a broader erosion of environmental health content, with noise largely absent or reduced to a subtopic within occupational health. This educational gap has significant implications: graduates often lack competencies in community exposure assessment, epidemiological interpretation, policy evaluation, and intersectoral interventions. Addressing the underrepresentation of noise in public health training is therefore a critical step toward mainstreaming noise as a determinant of health. Embedding core competencies on noise pollution in MPH curricula would enhance professional readiness, promote equity, and better align public health capacity with the scale of the problem.
Epidemiology and risk factors of malaria in Cabo Verde, 2015–2023, in the elimination era Graça Maria Carvalho Mendes Moniz* [1] , António Lima Moreira [2] , Adilson José DePina [3]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8078
Introduction: Cabo Verde was certified as malaria-free by the World Health Organization (WHO) in January 2024, becoming the fourth African nation to achieve this status. This study examines the epidemiological characteristics and associated factors of malaria cases in Cabo Verde from 2015 to 2023 to inform sustainable prevention strategies. Materials and methods: A retrospective, cross-sectional analysis was conducted using national surveillance data from 706 confirmed cases of malaria. Descriptive statistics and binary logistic regression were employed to identify factors associated with autochthonous versus imported cases. Statistical analyses were performed using SPSS v29.0.1.0. Results: Most cases (74.5%) occurred in males, with the highest incidence among individuals aged 20–54 years. The municipality of Praia accounted for 98.5% of autochthonous cases and 55% of imported cases. Fever (52.7%), headache (36.4%), and myalgia (20.4%) were the most common symptoms. Plasmodium falciparum caused all autochthonous infections, while imported cases included P. vivax, P. ovale, P. malariae, and mixed infections. Logistic regression identified fever (OR = 2.90; 95% CI: 1.24–6.78) and treatment with artemisinin-based combination therapy (ACT) plus primaquine (OR = 7.72; 95% CI: 1.12–53.29) as significant predictors of autochthonous cases. Chills were associated with imported cases (OR = 0.15; 95% CI: 0.07–0.29). Conclusions: Despite achieving malaria-free status, Cabo Verde remains vulnerable to imported cases due to its connectivity with endemic regions and receptivity level. Enhanced fever surveillance, targeted screening of travelers, and sustained vector control are critical to preventing reintroduction.
Environmental quality and global health Daniele Fattorini* [1,2]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8043
A growing scientific movement is investigating the complex and interconnected relationship between environmental degradation, infectious diseases, and global health, an approach often referred to as “One Health”. This paradigm challenges the long-held assumption that human health exists independently of the planet’s health. In the present review, three major global issues—environmental pollution, biodiversity loss, and climate change—are considered as key drivers of disease emergence and spread. Environmental pollution may affect the immune system, making living species, including humans, more vulnerable to infectious diseases. The COVID-19 pandemic highlighted this link, as studies in Italy and elsewhere correlated higher air pollution levels with increased spread and severity of the virus. Biodiversity loss, according to the “dilution effect” theory, can increase disease transmission. In ecosystems with a wide variety of species, pathogens are “diluted” because their vectors are more likely to encounter hosts that cannot transmit the disease. When biodiversity declines, however, “super-spreader” species that are effective at transmitting pathogens, such as certain rodents and bats, often dominate, increasing the risk of zoonotic spillovers. Finally, climate change exacerbates these issues by expanding the geographical range of disease vectors like mosquitoes and by creating extreme weather events that can lead to outbreaks of waterborne diseases. The present review addresses these issues by describing some key examples, such as the relationship between atmospheric contamination and the outbreak of infectious diseases, the role of biodiversity loss in Lyme disease, and the increase in the range of insect vectors of malaria and dengue associated with climate change. A multidisciplinary approach is fundamental to addressing these global challenges, suggesting collaboration between experts in human and veterinary medicine, developmental biology, environmental science and toxicology, and public policy, as well as the need to raise public awareness. This challenge could also be addressed through the advent of innovative technologies capable of significantly increasing our ability to access large multidisciplinary databases. Among these, artificial intelligence-based technologies could undoubtedly play a leading role.
viernes, 26 de diciembre de 2025
Why AI is a game-changer for faster, more targeted influenza vaccines
https://www.news-medical.net/whitepaper/20251223/Why-AI-is-a-game-changer-for-faster-more-targeted-influenza-vaccines.aspx
Influenza is responsible for a substantial amount of global illness and death every year. According to the World Health Organization (WHO), in February 2025, there were 3–5 million severe cases and 290,000 to 650,000 respiratory deaths worldwide resulting from seasonal flu epidemics.1
jueves, 25 de diciembre de 2025
Trump administration’s plan to shrink vaccine schedule sends health sector scrambling Hospitals and public health experts are uncertain how to address what would be a strikingly unusual change to U.S. vaccine policy
https://www.statnews.com/2025/12/23/trump-rfk-vaccine-schedule-healthcare-sector-considers-response/
By Daniel Payne, Chelsea Cirruzzo, and Helen BranswellDec. 23, 2025
How testosterone fell out of favor in medicine — and how it came back
Q&A with the doctor who pioneered modern testosterone treatment in America
https://www.statnews.com/2025/12/23/how-testosterone-treatment-was-rehabilitated-abraham-morgentaler-mens-health/
By Annalisa MerelliDec. 23, 2025
Contributing Writer
4 questions to understand the costs of ‘medical freedom’
Before policymakers change vaccine requirements, they need to ask these questions
https://www.statnews.com/2025/12/23/vaccine-policy-versus-medical-freedom-movement-4-questions/
How the Trump administration is recasting government’s role in regulating health technology
Agencies that used to set up and enforce guardrails now want to drive adoption of new, risky technologies
https://www.statnews.com/2025/12/23/trump-health-tech-ai-regulation/
By Casey Ross, Mario Aguilar, Katie Palmer, and Brittany TrangDec. 23, 2025
Rolling back health AI transparency rule will shift the burden of vetting to health systems The rule required disclosures around how clinical AI tools were developed and tested
https://www.statnews.com/2025/12/23/deregulating-health-ai-transparency-rule-shifts-burden/
By Casey RossDec. 23, 2025
Chief Investigative Reporter, Data & Technology
Major pharma companies may avoid Medicare experiments’ forced price cuts Some drugmakers that struck individual deals with Trump say they’re exempt from the Medicare effort
https://www.statnews.com/2025/12/23/trump-drug-pricing-deals-medicare-most-favored-nation-demos/
By John Wilkerson and Elaine ChenDec. 23, 2025
Proposed HHS rule on gender-affirming care radically expands use of Medicare, Medicaid as policy weapons If enacted, the rule will set a dangerous precedent
https://www.statnews.com/2025/12/24/gender-affirming-care-hhs-rule-medicare-medicaid-weapons/
By Carmel Shachar and Nicole HuberfeldDec. 24, 2025
Shachar is an assistant clinical professor of law at Harvard Law School. Huberfeld is Edward R. Utley professor of health law at Boston University School of Law & School of Public Health.
What giving flu shots backstage taught me about public health The performing arts world understands something increasingly disappearing from American life
https://www.statnews.com/2025/12/24/flu-shots-backstage-broadway-public-health/
By Ram KoppakaDec. 24, 2025
Koppaka is a public health physician and former senior CDC leader.
A Dose Of Upbeat And Inspiring News
A Dose Of Upbeat And Inspiring News
https://kffhealthnews.org/morning-breakout/a-dose-of-upbeat-and-inspiring-news-15/
Today's stories are about a paraplegic's trip to space, notable health care wins of 2025, philanthropy after loss, and a secret Santa's mission to boost the spirits of people in need.
ByHeart Formula Botulism Lawsuit Adds Target, Walmart, Whole Foods
ByHeart Formula Botulism Lawsuit Adds Target, Walmart, Whole Foods
The lawsuit has been brought against the infant formula maker on behalf of families whose babies were hospitalized with botulism. The plan to add the grocery store chains where the formula was sold to the lawsuits was announced on Sunday.
https://kffhealthnews.org/morning-breakout/byheart-formula-botulism-lawsuit-adds-target-walmart-whole-foods/
Nurses At 12 NYC Hospitals Prepared To Strike In New Year
Nurses At 12 NYC Hospitals Prepared To Strike In New Year
An end-of-year deadline sets up a potential work stoppage for about 20,000 nurses working at private hospitals in New York City. Other state health news is reported from North Carolina, Maine, Indiana, Illinois, Montana, and elsewhere.
https://kffhealthnews.org/morning-breakout/nurses-at-12-nyc-hospitals-prepared-to-strike-in-new-year/
New ALS Drug Targets Cell Mutation, May Slow Progression: Study
New ALS Drug Targets Cell Mutation, May Slow Progression: Study
The small study suggests that the drug, tofersen, might even be able to slow muscle degeneration and reverse ALS symptoms by targeting a specific mutation — SOD1 mRNA — which affects 2% of people with ALS. Plus: HIV drugs, a Nipah virus vaccine, hydroxychloroquine, and more.
https://kffhealthnews.org/morning-breakout/new-als-drug-targets-cell-mutation-may-slow-progression-study/
Aetna Adds IVF Coverage For Same-Sex Couples After Settlement
Aetna Adds IVF Coverage For Same-Sex Couples After Settlement
U.S. District Judge Haywood Gilliam, Jr. approved the agreement. Aetna will now cover IVF treatment for same-sex couples in the same way as heterosexual couples. This policy change will be applied nationally, and will benefit an estimated 2.8 million members.
https://kffhealthnews.org/morning-breakout/aetna-adds-ivf-coverage-for-same-sex-couples-after-settlement/
CMS Generates 400 Medicare-Funded Residency Slots
CMS Generates 400 Medicare-Funded Residency Slots
MedPage Today reports that the slots will be spread across 135 hospitals in 37 states, with almost two-thirds of them in primary care and psychiatry residency programs. Other health industry news is on medtech, CVS Health, outpatient cosmetic surgery, and more.
https://kffhealthnews.org/morning-breakout/cms-generates-400-medicare-funded-residency-slots/
Novo Nordisk’s Wegovy Becomes First GLP-1 Oral Pill After FDA Approval
Novo Nordisk’s Wegovy Becomes First GLP-1 Oral Pill After FDA Approval
The Wegovy pill has also been approved for reducing cardiovascular risks. Novo plans to launch the drug in January. Also in the news: the U.S. strikes health funding deals with nine African countries; Trump wants fewer guardrails on AI in health; and more.
https://kffhealthnews.org/morning-breakout/novo-nordisks-wegovy-becomes-first-glp-1-oral-pill-after-fda-approval/
miércoles, 24 de diciembre de 2025
February 10, 2026: Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products February 10, 2026
https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-product-application-pmta-submissions-electronic?utm_campaign=ctp-pmta&utm_content=event&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms
FDA Announces Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions
FDA has issued a Federal Register notice (FRN) announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on February 10, 2026, 9 am–5 pm ET. The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products.
Viewing the meeting is open to the public, however roundtable participants are limited to 30 individuals representing manufacturers who have previously submitted an ENDS PMTA, including those with a PMTA currently pending with FDA.
FDA is hosting this roundtable to provide small ENDS manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. The topics to be discussed will include certain components of ENDS PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).
To register for the roundtable as a panelist, please do so at the event page by January 27, 2026, 11:59 p.m. Eastern Time. Registration for panelists is on a rolling basis and is determined by space availability, with priority given to early registrants. FDA will evaluate registrations based on the submitted information until a maximum of 30 participants have been selected for the roundtable. Due to time and space constraints, there is a limit of one person to represent and speak on behalf of each company. Participants should be at a sufficiently senior level with significant scientific and/or regulatory responsibility to be knowledgeable about their company’s PMTA. Panel registrants will receive confirmation as to whether they have been selected. If panelist registration closes prior to the submission deadline, we will update the website to reflect that change.
For non-panelists and members of the public interested in viewing the roundtable virtually, information will be provided on CTP’s website. The meeting will be captioned and recorded. Please visit the event page to learn more about attending the roundtable.
AHRQ Stats: Insurance Coverage for Heart Disease Treatment
https://meps.ahrq.gov/data_stats/Pub_ProdResults_Details.jsp?pt=Statistical+Brief&opt=1&id=1316
AHRQ Stats: Insurance Coverage for Heart Disease Treatment
Medicare paid for 57.6 percent of heart disease treatment costs in 2022, the most of any insurance type. Private insurance was the second most common coverage source, accounting for 24.2 percent of costs. (Source: AHRQ Medical Expenditure Panel Survey Statistical Brief #562, Healthcare Expenditures for Heart Disease among Adults Aged 18 and Older in the U.S. Civilian Noninstitutionalized Population, 2022.)
Join AHRQ EPC Grand Rounds session Jan. 20 on Workplace Safety and Well-Being
https://effectivehealthcare.ahrq.gov/news/jan-2026-grand-rounds
January 20, 1–3 p.m. ET: AHRQ Evidence-based Practice Center Program Grand Rounds session on Workplace Safety and Well-Being
AHRQ Safety Program for HAI Prevention
https://safetyprogram4hai-prevention.ahrq.gov/page/home
AHRQ Safety Program for HAI Prevention: CAUTI Informational Webinar
January 13, 3–3:30 p.m. ET
January 22, 2–2:30 p.m. ET
Study Finds Over-the-Counter Hearing Aid Safe but Challenging to Set Up
An over-the-counter hearing aid for adults with mild to moderate hearing loss is safe but could be difficult for users to set up, according to an AHRQ-funded study. Published in JMIR Human Factors. The study tested the hearing aid with 41 adults to see how easy and safe it was to use before release to the general public. Researchers also tested whether people who should not use the device, such as those with severe hearing loss or tinnitus, could recognize whether it was appropriate for them to use. Common problems among users included pairing the hearing aids with a phone and being able to tell the right and left earbuds apart. Researchers recommended clearer instructions, larger print, and more visible warnings on the box and in the app to help consumers use the device correctly and safely. The manufacturer addressed most of the identified issues prior to commercial release, demonstrating the benefit of rigorous human factors evaluation of over-the-counter medical devices.
https://pubmed.ncbi.nlm.nih.gov/39834141/
Targeted Interventions Improve Imaging Recommendations and Diagnostic Safety
An AHRQ-funded study in Radiology found that specific interventions reduced recommendations for additional imaging by 44 percent and made the remaining recommendations 7.6 times more actionable. About 10 percent of radiology exams include recommendations for additional imaging, which are meant to help clarify diagnoses but may contribute to unnecessary testing when not actionable. Researchers analyzed more than 7.5 million radiology reports from 1,323,459 patients across two hospitals between 2015 and 2022, comparing a control site with one that implemented targeted interventions. These interventions—radiologist education, a closed-loop tracking tool, and personalized feedback—reduced the rate of additional imaging recommendations from 10 percent to 5.6 percent and increased the proportion of actionable recommendations from 5.6 percent to 42.3 percent, while rates at the control site remained stable. The results highlight the potential for targeted interventions to improve patient safety by reducing diagnostic errors, while also promoting more efficient and appropriate use of imaging across radiologic subspecialties.
https://pubs.rsna.org/doi/10.1148/radiol.243750
Antibiotics Overprescribed for Many Pediatric Infections at Discharge
Only one in five children discharged from the hospital with a diagnosis of infection received optimal prescriptions for antibiotics in both selection and duration, according to an AHRQ-funded study in Infection Control and Hospital Epidemiology. Researchers analyzed electronic health records from 1,206 encounters across four children’s hospitals with antibiotic stewardship programs throughout 2021, including 226 cases of community-acquired pneumonia, 417 urinary tract infections, and 563 skin or soft-tissue infections. They defined optimal prescribing as selecting medications and treatment durations recommended by national and hospital guidelines—for example, a 4- to 6-day course of amoxicillin for pneumonia. Overall, the choice of antibiotic was optimal in 77 percent of encounters, treatment duration was optimal in only 26 percent, and only 20 percent were optimal in choice and duration. The findings point to a need for stewardship interventions that target discharge prescribing, an area often overlooked in current programs.
https://pubmed.ncbi.nlm.nih.gov/40196890/
Statistical Brief Compares Telehealth Use in Metropolitan, Nonmetropolitan Areas
https://meps.ahrq.gov/mepsweb/data_stats/Pub_ProdResults_Details.jsp?pt=Statistical+Brief&opt=1&id=1326
As part of AHRQ’s stated priority to define appropriate and cost-effective use of telehealth, a new statistical brief from the agency’s Medical Expenditure Panel Survey (MEPS) project estimates the use of telehealth services between 2021 and 2023 for both rural and urban patients. Compared with patients in metropolitan areas, nonmetropolitan patients used telehealth services for a significantly smaller percentage of medical visits. While telehealth accounted for just over 26 percent of mental health visits in rural areas, urban patients used telehealth for nearly half of all mental health visits. The statistical brief also estimates telehealth use by insurance type and other patient and provider characteristics.
https://meps.ahrq.gov/mepsweb/
Diagnostic Safety Issue Briefs: Advance Diagnostic Safety With AHRQ’s Evidence-Based Issue Briefs
Diagnostic Safety Issue Briefs: .ib-mini { display: block; position: relative; width: 220px; min-height: 380px; float: left; margin: 10px 10px; padding: 10px 5px 5px 10px; } Starting in 2019, AHRQ supported the development of a series of papers on different diagnostic safety topics. The purpose of the papers was to develop, based on research conducted to date, more resources to improve diagnostic safety and quality, during a time when research to improve diagnostic safety was still an emerging field as compared to research to understand and prevent treatment-related mishaps.
AHRQ’s Diagnostic Safety Issue Briefs provide accessible, evidence-based guidance to support healthcare systems in advancing diagnostic safety and quality. Each brief describes key concepts, examines emerging challenges, and highlights approaches that can be readily applied in practice. Explore the resources below to deepen your understanding and identify strategies that can strengthen diagnostic performance across your organization.
Understanding the AI Wave: Foundational Knowledge for Improving Diagnosis and Beyond demystifies core artificial intelligence concepts and offers real-world examples to build foundational understanding. Grounded in evidence and informed by lessons from other high-risk industries, this issue brief provides practical, actionable guidance for healthcare leaders, clinicians, and patients.
Understanding the AI Wave: Foundational Knowledge for Improving Diagnosis and Beyond
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-ai-wave.html
Four Pillars for Sustainable Centers of Excellence was developed to support AHRQ’s Diagnostic Center of Excellence grantees in shaping their sustainability plans. It provides recommendations, examples, and success stories that can benefit any type of Center of Excellence.
Four Pillars for Sustainable Centers of Excellence
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-sustainability-centers-of-excellence.html
Exploration of Foundational Terminology and Paradigms for Improving Diagnosis explores different diagnostic terminology and offers questions that can help define which terms and definitions are most suitable for discussions about diagnosis.
Exploration of Foundational Terminology and Paradigms for Improving Diagnosis
https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-terminology.html
Introducing Academia Global and Public Health Matteo Charles Malvezzi* [1]
https://www.academia.edu/academia-global-and-public-health/1/1/10.20935/AcadPHealth8010
It is my honor to welcome you, the reader and prospective contributor, to Academia Global and Public Health. In this inaugural editorial, I would like to outline the future aims and scope of this journal. But before doing so, let me underscore what we consider to be our highest priority: being an author-centered journal built for scientific readers and contributors. Our mission is to build a bond of trust with our authors and readers. To achieve this, we will strive for quality over quantity, selecting published material with care and ensuring that the peer review process is fair, timely, and constructive.
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act December 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm_medium=email&utm_source=govdelivery
Today, the U.S. Food and Drug Administration issued a final guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act.”
The guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and Cosmetic Act (FD&C Act). It provides recommendations on the procedures, including formal dispute resolution (FDR), for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs that will be subject to a final order under section 505G of the FD&C Act. This guidance also outlines the procedures for an administrative hearing related to a final order. Finally, it describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes.
FDA committed to issuing a guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017). For efficiency, rather than amending FDA’s existing FDR guidance to include FDR procedures for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.
https://www.fda.gov/media/106407/download?utm_medium=email&utm_source=govdelivery
Read the Federal Register notice for additional information.
https://www.federalregister.gov/documents/2025/12/23/2025-23707/formal-dispute-resolution-and-administrative-hearings-of-final-administrative-orders-under-section
For more information, including frequently asked questions about OTC monographs, visit OTC Monographs@FDA.
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder ++++
News & Perspectives:
How Old Is ‘Current’ and Why Do Users Confide in Chatbots?
How Old Is ‘Current’ and Why Do Users Confide in Chatbots?
Ute Eppinger
https://www.medscape.com/viewarticle/how-old-current-and-why-do-users-confide-chatbots-2025a100102a?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
How to Get ChatGPT to Recommend Thalidomide to a Pregnant Woman
How to Get ChatGPT to Recommend Thalidomide to a Pregnant Woman
F. Perry Wilson, MD, MSCE
https://www.medscape.com/viewarticle/how-get-chatgpt-recommend-thalidomide-pregnant-woman-2025a1001010?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder
FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder
Tara Haelle
https://www.medscape.com/viewarticle/fda-expands-flibanserin-approval-postmenopausal-women-2025a100102d?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
December 23, 2025
You Can’t Bargain-Buy Nursing: Lessons From Milan’s ICU
You Can’t Bargain-Buy Nursing: Lessons From Milan’s ICU
Roberta Villa, MD
https://www.medscape.com/viewarticle/you-cant-bargain-buy-nursing-lessons-milans-icu-2025a100102b?ecd=wnl_edit_tpal_etid7981416&uac=148436CN&impID=7981416
martes, 23 de diciembre de 2025
Trump administration proposes Medicare pilots to lower drug prices on par with peer countries The plans could save Medicare billions and reduce patients’ out-of-pocket costs
https://www.statnews.com/2025/12/22/trump-medicare-demonstrations-most-favored-nation-lower-drug-prices/
By John Wilkerson and Daniel PayneDec. 22, 2025
Pharmaceutical industry evades drug price transparency, again The actual prices paid for prescription drugs will remain out of public view
https://www.statnews.com/2025/12/22/trump-delays-drug-price-transparency-drug-companies-pbm/
By Bob HermanDec. 22, 2025
Business of Health Care Reporter
Trump administration to scrap federal rule requiring transparency into health AI tools The move could make it easier for health systems to adopt AI, while leaving patients vulnerable
https://www.statnews.com/2025/12/22/hhs-proposes-scrapping-ai-model-cards-transparency-rule/
By Casey RossDec. 22, 2025
Chief Investigative Reporter, Data & Technology
4 questions to understand the costs of ‘medical freedom’ Before policymakers change vaccine requirements, they need to ask these questions
https://www.statnews.com/2025/12/23/vaccine-policy-versus-medical-freedom-movement-4-questions/
By Sarah DespresDec. 23, 2025
Despres is a public health expert who served as a counselor to the secretary of Health and Human Services from 2021 to 2025.
China biotech’s Cambrian explosion In China’s biotech sector, hypercompetition and speed are rewriting the rules of drug discovery
https://www.statnews.com/2025/12/23/china-drug-discovery-serendipity-competition/
By Brian FinrowDec. 23, 2025
Finrow is CEO, co-founder, and co-chairman of Lumen Bioscience.
FDA approves pill version of Novo Nordisk’s Wegovy, possibly widening access Oral version led to similar efficacy as the injectable weight loss treatment in clinical trial
https://www.statnews.com/2025/12/22/wegovy-pill-oral-weight-loss-treatment-approved/
By Elaine ChenDec. 22, 2025
National Biotech Reporter
How testosterone fell out of favor in medicine — and how it came back Q&A with the doctor who pioneered modern testosterone treatment in America
https://www.statnews.com/2025/12/23/how-testosterone-treatment-was-rehabilitated-abraham-morgentaler-mens-health/
By Annalisa MerelliDec. 23, 2025
Contributing Writer
How the Trump administration is recasting government’s role in regulating health technology Agencies that used to set up and enforce guardrails now want to drive adoption of new, risky technologies
https://www.statnews.com/2025/12/23/trump-health-tech-ai-regulation/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_jjlyg5GXouoeHlgYjVYsel_KnRRSnogMQRFsXYw4DAz-4PTMaYk9pnmi61ayWn3ETzKp1qIdTc1EaaXkoB9s1qXfPGw&_hsmi=395702425&utm_content=395702425&utm_source=hs_email
By Casey Ross, Mario Aguilar, Katie Palmer, and Brittany TrangDec. 23, 2025
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=97&utm_medium=email&utm_source=govdelivery
FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
The U.S. Food and Drug Administration (FDA) qualified total hip bone mineral density (BMD) as assessed by dual energy X-ray absorptiometry (DXA) as a validated surrogate endpoint to support clinical trials of investigational therapies for post-menopausal women with osteoporosis at risk for fracture.
Osteoporosis-related fractures represent a major public health challenge, affecting one in two women and one in four men over age 50. Despite the availability of effective FDA-approved therapies, there remains an urgent need for new osteoporosis medications with improved safety profiles and efficacy.
Traditional clinical trials for anti-osteoporosis drugs have required fracture endpoints as primary efficacy measures, necessitating large studies that can take two to five years. Qualifying BMD as a surrogate endpoint would allow for more efficient clinical trials, potentially enabling faster approval of new osteoporosis treatments and improving patient access. A BMD test measures calcium and other minerals in the bones, with more minerals indicating denser bones that are less prone to fracture.
The qualified tool is the percentage change from baseline at 24 months in total hip BMD assessed by DXA. This biomarker can be used as a validated surrogate endpoint for assessment of investigational therapies for post-menopausal women with osteoporosis at risk for fracture in phase 3 clinical trials, providing an alternative to fracture endpoints.
Drug development tools play an important role in bringing new therapies to patients by providing well-defined, scientifically sound approaches to clinical trial design and regulatory decision-making.
Drug Development Tool (DDT) Qualification Programs
https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act December 2025
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-dispute-resolution-and-administrative-hearings-final-administrative-orders-under-section-505g?utm_medium=email&utm_source=govdelivery
FDA Issues Final Guidance About Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs
Today, the U.S. Food and Drug Administration issued a final guidance for industry titled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug and Cosmetic Act.”
The guidance provides recommendations on the formal dispute and administrative hearing procedures with respect to final orders under section 505G of the Food, Drug and Cosmetic Act (FD&C Act). It provides recommendations on the procedures, including formal dispute resolution (FDR), for resolving scientific and/or medical disputes between CDER and requestors and sponsors of over-the-counter (OTC) monograph drugs that will be subject to a final order under section 505G of the FD&C Act. This guidance also outlines the procedures for an administrative hearing related to a final order. Finally, it describes the procedures for consolidated proceedings for FDR and hearings to resolve the scientific and/or medical disputes.
FDA committed to issuing a guidance on consolidated proceedings and updating the existing CDER FDR guidance, CDER Formal Dispute Resolution: Sponsor Appeals Above the Division Level (Nov. 2017). For efficiency, rather than amending FDA’s existing FDR guidance to include FDR procedures for final orders and issuing a separate guidance for consolidated proceedings for appeals, FDA is issuing this single draft guidance.
New Trump Administration Proposals Would Further Limit Gender Affirming Care for Young People by Restricting Providers and Reducing Coverage Authors: Lindsey Dawson and Scott Hulver Published: Dec 22, 2025
https://www.kff.org/lgbtq/new-trump-administration-proposals-would-further-limit-gender-affirming-care-for-young-people-by-restricting-providers-and-reducing-coverage/?utm_campaign=31978628-KFF-LGBTQ&utm_medium=email&_hsenc=p2ANqtz--9OXbX068T4x1UQ0OVUMEhdhUc-FrWGHcTYf095Oy_ws7FZTfQwaPHPWn9E6c2vG4FZQ2wLHrWIOf9UlFSui95XXXCIg&_hsmi=395626533&utm_content=395626533&utm_source=hs_email
Examining Newly Proposed Federal Rules That Would Further Limit Youth Access to Gender Affirming Care
Following the release of two proposed federal rules that aim to further limit youth access to gender affirming care, KFF examines what they include and what they could mean for transgender youth who seek this care, and for their providers. These rules align with a Trump Administration Executive Order released earlier this year and build on a range of other state and administrative actions intended to limit access to gender affirming care.
One proposed rule prohibits the provision of certain gender affirming care services as a condition of hospital participation in Medicare and Medicaid. The KFF brief reviews the implications, which include restricting care access in most hospitals, including for patients with private insurance. With Medicare and Medicaid accounting for almost half of spending on care in hospitals, if the rule were finalized, hospitals are unlikely to continue providing gender affirming care.
The other proposed rule would ban federal Medicaid and Children's Health Insurance Program payments for the same types of care across all providers (not just hospitals). As the KFF brief explains, this proposed rule would have a significant — though uneven — impact on access, limiting coverage for families who would find paying for gender affirming care out-of-pocket most challenging.
The public has 60 days to comment on the rules, after which the administration could modify or take action to finalize them. If finalized, they are likely to face legal challenges.
CONTACT:
Craig Palosky | 202.654.1369| CraigP@kff.org
Expat MD: The Ultimate Guide to Working Abroad
https://www.medscape.com/viewcollection/37936?ecd=spec-page_expatmd
Physicians are increasingly trading familiar turf for new challenges and opportunities. With nearly 19% of doctors in OECD countries now foreign-trained — and migration rising — this collection explores how doctors from around the world make the leap abroad, what regulatory hurdles await them, and what life really looks like once they land. Dive into detailed country guides and frank personal stories of ambition, adaptation, and the unexpected.
lunes, 22 de diciembre de 2025
EURORDIS welcomes the Commission’s ‘promising’ Biotech Act I December 2025
EURORDIS welcomes the Commission’s ‘promising’ Biotech Act I
December 2025
16 December 2025, Strasbourg – While EURORDIS–Rare Diseases Europe will take more time to analyse the European Commission’s Biotech Act I proposals in detail, we welcome this important step towards strengthening Europe’s capacity to innovate in health and translate scientific progress into tangible benefits for society.
https://www.eurordis.org/eurordis-welcomes-commissions-biotech-act-i/
There is No Drop-Dead Date for an ACA Tax Credit Extension, But Coverage Losses Will Mount as the Clock Ticks
https://www.kff.org/quick-take/there-is-no-drop-dead-date-for-an-aca-tax-credit-extension-but-coverage-losses-will-mount-as-the-clock-ticks/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-927xI3WG7ee7INSs2sWhiapU7sm9n-qYlBJnIPFM1DDog3GmV6ipeFlpCs9enowng484ee_OkhmDhsh-Rf0Vqao9TGWA&_hsmi=395312363&utm_content=395312363&utm_source=hs_email
A discharge petition in the House paves the way for a vote on a three-year extension of the tax credits, which would provide ACA enrollees premium relief whenever it comes. While there is still time to extend the enhanced tax credits, with each passing day, more and more ACA Marketplace enrollees are going to drop their health insurance when faced with eye-popping increases in their premium payments, writes KFF’s Larry Levitt.
Mass General Brigham bolstered its bottom line. Other Mass. hospital groups reported multimillion losses The different finances and outlooks of the hospitals in the state are mirrored nationwide
https://www.statnews.com/2025/12/21/mass-general-brigham-finances/
By Jessica Bartlett — Boston GlobeDec. 21, 2025
A seasoned biotech VC looks to 2026 and sees a wave of IPOs coming Atlas Venture’s Bruce Booth believes more drugmakers are ready to access public markets
https://www.statnews.com/2025/12/22/biotech-public-companies-ipos/
By Allison DeAngelisDec. 22, 2025
Biotech Startups and Venture Capital Reporter
Researchers have a moral obligation to push back when their studies are twisted to promote false health claims Studies give a gloss of authenticity to bogus ideas. Researchers must fight back
https://www.statnews.com/2025/12/22/research-misrepresented-vaccines-newsguard/
By John GregoryDec. 22, 2025
Gregory is health editor for NewsGuard.
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