Archived documents
Documents past their public comment period for Healthcare & Public Health.
PSG_009218-Sol - Draft Guidance on Warfarin Sodium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PSG_009218 - Draft Guidance on Warfarin Sodium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PSG_218785 - Draft Guidance on Zanubrutinib
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Second Amendment to ANDA Suitability Petition from Luitpold Pharmaceuticals Inc
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Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability
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Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry DRAFT GUIDANCE
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Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
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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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE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Topical Dermatologic Corticosteroids In Vivo Bioequivalence - DRAFT Guidance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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Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Draft Guidance
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