STAT

Experts worry FDA’s credibility is being shredded by scandal and ‘soap opera’

It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, ...
Health Affairs

District Court: Restrictions On Mifepristone Illegal But Will Remain In Effect Pending FDA Reconsideration

In any review of mifepristone, the FDA will now have to grapple with Judge Otake’s conclusion that the 2023 REMS decision for ...
JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Clinical Advisor

FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs

Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
CURE

FDA Approves Stoboclo and Osenvelt as Biosimilars for Some Cancers

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

UniQure shares plummet as FDA says inadequate clinical data for Huntington's therapy

UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy for Huntington's disease may be adequate for a marketing application, ...

US FDA's drug division chief resigns amid ethics concerns and lawsuit

The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about his personal conduct, a Department of ...
Opinion
The ColumbianOpinion

Jarvis: FDA’s mifepristone decision sows confusion

The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to interpret ...