FDA Generic Drug Reviews Routinely Delayed: Study

Law360, New York (June 16, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration was unable to review nearly half of all generic drug applications on time because of a problematic review system and insufficient funds and staff, according to an inspector general's report released Friday.

Department of Health and Human Services Inspector General Daniel Levinson looked at the timing of the FDA's reviews in 2006 for 989 generic drug applications, which are filed by companies seeking approval to sell cheaper versions of brand-name drugs.

The study found that the FDA approved or tentatively...
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