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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
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act _1  Food and Drug Administration (FDA) Final
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act  Food and Drug Administration (FDA) Final
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997  Food and Drug Administration (FDA) Final
Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns  Food and Drug Administration (FDA) Final
Requests for Reconsideration at the Division Level Under GDUFA  Food and Drug Administration (FDA) Final
Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry  Food and Drug Administration (FDA) Final
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry  Food and Drug Administration (FDA) Final
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.