viernes, 1 de mayo de 2026

Katherine Szarama named acting director of FDA’s vaccines and biologics center Szarama was deputy to Vinay Prasad, who just left the agency

https://www.statnews.com/2026/04/30/fda-names-katherine-szarama-acting-director-cber/ By Lizzy LawrenceApril 30, 2026 FDA Reporter

Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood Venter died on Wednesday at 79, having transformed genomics

https://www.statnews.com/2026/04/30/craig-venter-an-appreciation-pioneer-modern-genomics-dies-age-79/ By Matthew HerperApril 30, 2026 Senior Writer, Medicine, Editorial Director of Events

OxyContin maker Purdue Pharma set to dissolve after judge approves its criminal sentence ‘It is not lost on me that those who started the epidemic will not serve a sentence,’ the judge said

https://www.statnews.com/2026/04/30/oxycontin-maker-purdue-pharma-will-dissolve-criminal-sentence-approved/ By Associated PressApril 30, 2026

The psychedelic revolution is leaving behind people of color Racial minorities could gain a lot from psychedelics, but so far, they aren’t

https://www.statnews.com/2026/05/01/psychedelics-law-black-hispanic-indigenous-groups-research/ By Jerel Ezell and Sugy ChoiMay 1, 2026 Ezell is a social epidemiologist and assistant professor at the University of Chicago Medical Center. Choi is a health services researcher and assistant professor at New York University Grossman School of Medicine.

America is worrying about fertility again. But it’s not really about families There’s a fine line between a pro-family agenda and a coercive one

https://www.statnews.com/2026/05/01/america-birth-rate-decline-fertility-eugenics-policy/ By Sonya Borrero, Christine Dehlendorf, and Rachel LoganMay 1, 2026 Borrero, Dehlendorf, and Logan are authors of the forthcoming book “Reproducing Control: The Family Planning Framework’s Conflict with Reproductive Autonomy.”

Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more After a prior effort shuttered, Julia Vitarello is trying again

https://www.statnews.com/2026/05/01/biotech-julia-vitarello-scaling-custom-therapy-everyone-medicines/ By Andrew JosephMay 1, 2026 Europe Correspondent

As artificial intelligence shows off diagnostic chops, scientists reckon with the way forward A prominent study in Science prompts physicians to call for rigorous clinical trials

https://www.statnews.com/2026/04/30/open-ai-llm-model-outperforms-doctors-study-published-journal-science By Katie PalmerApril 30, 2026 Health Tech Correspondent

‘Forever chemicals’ in baby formula? Scientists unpack FDA results Many formulas are PFAS-free, but experts say more should be done to protect infants

https://www.statnews.com/2026/05/01/fda-infant-formula-safety-pfas-forever-chemical-levels-analyzed/ By Sarah ToddMay 1, 2026 Reporter, Commercial Determinants of Health

In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA ‘Questioning the vaccine schedule, that doesn’t mean you’re anti-vax’

https://www.statnews.com/2026/04/30/surgeon-general-nominee-nicole-saphier-in-her-own-words/ By Elizabeth Cooney, Helen Branswell, and Katie PalmerApril 30, 2026

Drug Amount Reporting: FDA Publicly Identifies over 7,700 Noncompliant Companies May 1, 2026 By Fabiola C. Gomez, Ph.D., CMC Regulatory Expert —

https://www.thefdalawblog.com/2026/05/drug-amount-reporting-fda-publicly-identifies-over-7700-noncompliant-companies/?utm_source=rss&utm_medium=rss&utm_campaign=drug-amount-reporting-fda-publicly-identifies-over-7700-noncompliant-companies On March 31, 2026, the FDA published a list of companies that have not submitted required drug amount reports for calendar year 2024. For stakeholders involved in drug manufacturing, this update highlights both a critical regulatory requirement and a compliance gap across the industry.

Webinar – Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge June 24, 2026

https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-reducing-readmissions-through-device-innovation-home-readi-home-innovation-challenge?utm_medium=email&utm_source=govdelivery Webinar – Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge The U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested parties to discuss the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge. The goal of this Innovation Challenge, which is part of the FDA’s Center for Devices and Radiological Health’s (CDRH) Home as a Health Care Hub Initiative, is to accelerate patient access to medical device technologies aimed at reducing hospital readmission. Innovation in this area has the potential to reduce morbidity and mortality associated with chronic conditions and significantly reduce the financial and logistical burden on the health care system Date: June 24, 2026 Time: 1:00 – 2:00 p.m. ET Registration is required. https://www.fda.gov/medical-devices/home-health-care-hub/fda-readi-home-innovation-challenge-reducing-readmissions-through-device-innovation-home?utm_medium=email&utm_source=govdelivery