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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 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
PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide  Food and Drug Administration (FDA) Final
Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601  Food and Drug Administration (FDA) Final
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Final
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.