Drug Safety Reform: Did FDA Buy Time or Trouble?

FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.

By Cole Werble

It seemed like a good idea at the time. Fifteen months ago, the Food & Drug Administration, under intense pressure...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Agency Leadership

More from Pink Sheet