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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
Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors: Memorandum to Licensed Establishments  Food and Drug Administration (FDA) Final
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma Establishments  Food and Drug Administration (FDA) Final
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV): Memorandum to Registered Blood and Plasma Establishments  Food and Drug Administration (FDA) Final
PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline  Food and Drug Administration (FDA) Final
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies  Food and Drug Administration (FDA) Final
Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods  Food and Drug Administration (FDA) Final
Accelerated Approval – Expedited Program for Serious Conditions  Food and Drug Administration (FDA) Proposed
CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4128 documents.