Jenkins defends approvable letters

Share this article:
A recent controversy about the FDA ducking its legal obligation to approve new drugs on time by issuing "approvable" letters is just silly, said FDA director of new drugs John Jenkins. He was also annoyed by the media's slowness to educate themselves.

An “approvable” letter allows the sponsor to submit additional information for FDA consideration, leading some to say the agency is more risk-averse in the wake of the Vioxx withdrawal.

Jenkins said at the Drug Information Association's annual meeting in Philadelphia in June that public comments on these letters “is really a kind of silly way of looking at data and very short-lived numbers.”

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Legal/Regulatory

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.