Report Materials
This final audit report points out that the Food and Drug Administration (FDA) has not taken sufficient action to correct a material weakness in FDA's generic drug approval process. The FDA needs to: (1) modify the method by which generic drug applications are assigned to reviewers to remove any opportunity for showing partiality or favoritism; (2) revise its "first-in, first-reviewed" policy for generic drugs because the current policy may allow for the unequal treatment of drug firms' applications; (3) develop comprehensive guidelines to assure that generic drug applications are reviewed in a uniform and consistent manner; and (4) establish a quality control review system outside the Office of Generic Drugs to ensure the propriety of individual generic drug application reviews and the integrity of the review process.
Notice
This report may be subject to section 5274 of the National Defense Authorization Act Fiscal Year 2023, 117 Pub. L. 263.