3min chapter

Open to Debate cover image

Is the FDA Too Cautious?

Open to Debate

CHAPTER

The FDA's Accelerated Approval of the Alzheimer Drug

FDA gave accelerated approval to a drug where the evidence wasn't there, and their own advisory committee voted against it. The problem is that studies take a long time to get done; moreover, drugs do come to market and they turn out to be non-confermatory. "The issue in the FDA is not to approve or not approve fast or not," says Dr. Colin Rieckhoff.

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