News

FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say

Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
BioSpace13d

FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
Fierce Biotech1d

Adaptimmune sells 4 cell therapies to pharma for $55M, plans layoffs

After months of searching for strategic options, Adaptimmune is offloading its cell therapies to a global pharma, which plans ...
Medical Device Network on MSN1d

AI at the FDA: help or hindrance?

The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.
Hoodline9d

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
Devdiscourse10d

Sarepta Defies FDA Order Amidst Gene Therapy Controversies

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...
STAT11d

Inside an FDA drug rejection, and layoffs at Sarepta

Just how many employees is Sarepta Therapeutics laying off? And why did the FDA reject Ultragenyx's rare disease drug over ...

Thousands Laid off From NIH, FDA and CDC After Supreme Court Decision

On Monday, the U.S. Department of Health and Human Services (HHS) finalized 10,000 layoffs across federal health agencies, ...
HealthLeaders Media21d

FDA Layoffs Could Compromise Safety of Medications Made at Foreign ...

Beyond staff cuts, the departures of investigators in recent months have left less experienced people tasked with rooting out dangerous manufacturing practices.
MM&M22d

FDA layoffs could compromise safety of medications made at foreign ...

Policy FDA layoffs could compromise safety of medications made at foreign factories, inspectors say Beyond staff cuts, the departures of some longtime investigators in recent months have left less ...