OIG Reports On FDA Generic Drug Review Process - Pharmaceutical Manufacturers And Sponsors Be Aware.

Mondaq Business BriefingNbr. 2008, March 2008

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U.S. Department of Health and Human Services - United States. Food and Drug Administration

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OIG Reports On FDA Generic Drug Review Process - Pharmaceutical Manufacturers And Sponsors Be Aware.

On June 13, 2008, the Office of Inspector General for the U.S. Department of Health and Human Services (the "OIG") released its report entitled "The Food and Drug Administration's Generic Drug Review Process." The report outlined the evaluation process for Abbreviated New Drug Applications ("ANDAs") as well as how long the evaluations to...

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