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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
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry  Food and Drug Administration (FDA) Proposed
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance  Food and Drug Administration (FDA) Proposed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
Proposed Rule: Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449-P)  Centers for Medicare & Medicaid Services (CMS) Proposed
Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products  Food and Drug Administration (FDA) Proposed
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5483 documents.