Archived documents
Documents past their public comment period for Pharmaceutical Policy.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
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Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
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Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
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Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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Citizen Petition from Apotex Inc.
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Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
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List of Bulk Drug Substances for which there Is a Clinical Need the Federal Food, Drug, and Cosmetic Act
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