I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research.

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

The FDA is moving to scale back its long-standing use of expert panels to review drug applications, KFF Health News reported Sept. 12. George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug ...

Travere Therapeutics (TVTX) on Wednesday said that the U.S. Food and Drug Administration informed the company that it has ...

The U.S. Food and Drug Administration will hold an advisory panel meeting in November to examine the fast-emerging class of ...

The FDA will convene experts on Nov. 6 to discuss challenges around regulating mental health products that use artificial ...

Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval ...

The US Food and Drug Administration (FDA) will hold an advisory panel meeting in November to examine the fast-emerging class ...

G. Caleb Alexander has chaired or served on more than a dozen FDA advisory committees. He’s worried the shift to ‘expert’ ...