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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
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
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance  Food and Drug Administration (FDA) Final
Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry  Food and Drug Administration (FDA) Final
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products  Food and Drug Administration (FDA) Final
Plasma Derived from Therapeutic Plasma Exchange  Food and Drug Administration (FDA) Final
Points to Consider for Cervical Cytology Devices  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.