Archived documents
Documents past their public comment period for Pharmaceutical Policy.
PSG_203214 - Draft Guidance on Tofacitinib Citrate
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PSG_019594 - Draft Guidance on Ursodiol
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PSG_009218-Sol - Draft Guidance on Warfarin Sodium
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PSG_009218 - Draft Guidance on Warfarin Sodium
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PSG_218785 - Draft Guidance on Zanubrutinib
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Citizen Petition from Fresenius Kabi USA, LLC
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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE
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Topical Dermatologic Corticosteroids In Vivo Bioequivalence - DRAFT Guidance
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Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program
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Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs
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