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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
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Postoperative Nausea and Vomiting: Developing Drugs for Prevention  Food and Drug Administration (FDA) Proposed
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens  Food and Drug Administration (FDA) Proposed
Potency Assurance for Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  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
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Psychedelic Drugs: Considerations for Clinical Investigations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.