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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 Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations  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 Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Pharmacogenomic Data Submissions  Food and Drug Administration (FDA) Proposed
Pharmacogenomic Data Submissions — Companion Guidance  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Final
Platform Technology Designation Program for Drug Development  Food and Drug Administration (FDA) Proposed
Post-Warning Letter Meetings Under GDUFA  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4040 documents.