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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
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
Platform Technology Designation Program for Drug Development  Food and Drug Administration (FDA) Proposed
Post-Warning Letter Meetings Under GDUFA  Food and Drug Administration (FDA) Final
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
Postapproval Pregnancy Safety Studies Guidance for Industry  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
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
This Guidance Portal contains 4741 documents.