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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
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide  Food and Drug Administration (FDA) Final
OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen  Food and Drug Administration (FDA) Final
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval  Food and Drug Administration (FDA) Final
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers  Food and Drug Administration (FDA) Final
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Final
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input  Food and Drug Administration (FDA) Final
PDEs for Triethylamine and for Methylisobutylketone  Food and Drug Administration (FDA) Final
PDUFA Pilot Project: Proprietary Name Review - Concept Paper  Food and Drug Administration (FDA) Final
Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.