March 4, 2006
Post-Approval Studies: Still Waiting...
According to the NYT:
When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.
Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs' approval.
I'd hate to be defense counsel when one of those promised studies dealt with the adverse event alleged.
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