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Pharmaceuticals / Regulatory Affairs

GAO Flags Variations in FDA Comments to Generic Drug Applicants

Aug. 13, 2019
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The FDA should look into inconsistencies in its written comments to generic drug applicants to improve approval rates, the Government Accountability Office (GAO) says in a report.

GAO’s review of 35 generic drug applications revealed varying levels of clarity and content in the FDA’s comments to applicants that may have impacted whether they could fix deficiencies  during the first cycle and attain approval. For example, multiple applicants complained about a “lack of clarity in the information required” that kept them from properly addressing the agency’s feedback.

GAO urged the agency to “take additional steps to address inconsistency in its written comments to generic drug applicants — including the clarity of writing and the content of comments — among reviewers, such as requiring additional training for reviewers.”

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