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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
Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry  Food and Drug Administration (FDA) Final
Q8(R2) Pharmaceutical Development  Food and Drug Administration (FDA) Final
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for Industry: Letter Regarding Point of Purchase Food Labeling  Food and Drug Administration (FDA) Final
Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information  Food and Drug Administration (FDA) Final
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff  Food and Drug Administration (FDA) Proposed
TANF-ACF-PI-2009-06 (Questions and Answers on the TANF Contingency Fund (separate from the Emergency Contingency Fund authorized by the American Recovery and Reinvestment Act of 2009))  Administration for Children and Families (ACF) Final
This Guidance Portal contains 4744 documents.