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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for Industry  Food and Drug Administration (FDA) Final
Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry  Food and Drug Administration (FDA) Final
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.