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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
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)  Food and Drug Administration (FDA) Final
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19  Food and Drug Administration (FDA) Final
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA  Food and Drug Administration (FDA) Final
Review of FDA's Implementation of the Drug Export Amendments of 1986  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.