Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Psychedelic Drugs: Considerations for Clinical Investigations  Food and Drug Administration (FDA) Proposed
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Pulmonary Tuberculosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.