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
Consumer-Directed Broadcast Advertisements: Guidance for Industry  Food and Drug Administration (FDA) Final
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention: Guidance for Industry  Food and Drug Administration (FDA) Final
Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.