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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
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities: Guidance for Industry  Food and Drug Administration (FDA) Final
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry  Food and Drug Administration (FDA) Final
Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection: Guidance for Industry  Food and Drug Administration (FDA) Final
Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for Industry  Food and Drug Administration (FDA) Final
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Residual Drug in Transdermal and Related Drug Delivery Systems: Guidance for Industry  Food and Drug Administration (FDA) Final
Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.