S 2513
OTC Monograph Drug User Fee Transparency Act
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- Passed Senate
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Bill overview
This bill, the OTC Monograph Drug User Fee Transparency Act, aims to increase transparency and accountability in the Food and Drug Administration’s (FDA) oversight of over-the-counter (OTC) drug monographs. It requires the FDA to provide detailed reports on its progress in meeting goals related to monograph orders, postmarket safety activities, and registration of manufacturing facilities. Furthermore, the bill mandates the public release of minutes from negotiations between the FDA and the regulated industry and directs the Government Accountability Office (GAO) to assess the stability of the OTC monograph drug supply chain.
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