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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
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Reformulating Drug Products That Contain Carbomers Manufactured With Benzene  Food and Drug Administration (FDA) Final
Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Regulatory Classification of Pharmaceutical Co-Crystals  Food and Drug Administration (FDA) Final
Remote Interlock Connectors (Laser Notice 11)  Food and Drug Administration (FDA) Final
REMS Document Technical Conformance Guide  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4048 documents.