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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
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
Pediatric HIV Infection: Drug Development for Treatment  Food and Drug Administration (FDA) Final
Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice  Food and Drug Administration (FDA) Final
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans  Food and Drug Administration (FDA) Final
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide  Food and Drug Administration (FDA) Final
PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011  Food and Drug Administration (FDA) Final
PET Drug Applications - Content and Format for NDAs and ANDAs_2011  Food and Drug Administration (FDA) Final
PET Drug Products - Current Good Manufacturing Practice (CGMP)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.