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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
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Over-the-Counter Monograph Order Requests: Format and Content  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making  Food and Drug Administration (FDA) Proposed
Psychedelic Drugs: Considerations for Clinical Investigations  Food and Drug Administration (FDA) Proposed
Postoperative Nausea and Vomiting: Developing Drugs for Prevention  Food and Drug Administration (FDA) Proposed
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Changes to Drug Substances Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers  Food and Drug Administration (FDA) Proposed
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Potency Assurance for Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5570 documents.