OIG report: FDA review of generic ANDAs comes up short


OIG has released a report on FDA's generic drug review process.

The Department of Health & Human Services Office of Inspector General (OIG) has released the Food & Drug Administration's Generic Drug Review Process report. Among the findings: The FDA approved or tentatively approved 4% of original Abbreviated New Drug Applications (ANDAs) under review in 2006; the remaining 96% did not meet review standards and were disapproved; the FDA exceeded the 180-day review requirement for nearly half of original ANDAs under review in 2006 because Chemistry reviews exceeded 180 days; Microbiology, Bioequivalence, and Labeling reviews of original ANDAs generally exceeded 180 days in 2006.

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