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Safety of FDA's Biologic Laboratories
This September 2020 report was prepared by the Government Accountability Office (GAO) to study concerns about the oversight of FDA laboratories that conduct research in hazardous biological agents. Initiated to evaluate practices cited in a 2016 report, GAO makes five recommendations to FDA. including roles and responsibilities for lab safety, overall safety strategy, and clear definition of oversight authority. An appendix includes FDA's reaction to the report.