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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
Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act  Food and Drug Administration (FDA) Proposed
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations  Food and Drug Administration (FDA) Proposed
PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR  Food and Drug Administration (FDA) Proposed
Medical Gases — Current Good Manufacturing Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event  Food and Drug Administration (FDA) Proposed
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4126 documents.