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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
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry  Food and Drug Administration (FDA) Proposed
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
How to Comply with the Pediatric Research Equity Act  Food and Drug Administration (FDA) Proposed
How To Obtain a Covered Product Authorization  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
Identifying Trading Partners Under the Drug Supply Chain Security 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
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.