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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
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment  Food and Drug Administration (FDA) Proposed
Guidance for Industry 180-Day Exclusivity: Questions and Answers  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials  Food and Drug Administration (FDA) Proposed
How to Comply with the Pediatric Research Equity Act  Food and Drug Administration (FDA) Proposed
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Identifying Trading Partners Under the Drug Supply Chain Security Act  Food and Drug Administration (FDA) Proposed
Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
How To Obtain a Covered Product Authorization  Food and Drug Administration (FDA) Proposed
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Guide pour l’industrie: Questions et réponses concernant le Registre de denrées alimentaires à signaler Reportable Food Registry (RFR) tel qu’établi par le Food and Drug Administration Amendments Act de 2007 (FDAAA) (2ème édition)  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4742 documents.