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Documents past their public comment period for FDA.
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Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Draft Guidance
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Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
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Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
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Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
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Determination of Regulatory Review Period for Purposes of Patent Extension; ZIIHERA
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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Agency Information Collection Activities; Proposals, Submissions, and Approvals: Required Warnings for Cigarette Packages and Advertisements
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe Processing and Importing of Fish and Fishery Products
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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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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