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
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers  Food and Drug Administration (FDA) Final
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants  Food and Drug Administration (FDA) Proposed
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Enforcement Policy to Delay Requirements to Submit International Mail Tracking Number and Mail Service Name Until May 1, 2027: Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Advisory Opinion 26-02  Office of the General Counsel (OGC) Final
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility  Food and Drug Administration (FDA) Final
Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CVM GFI #298 (VICH GL62) – Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11384 documents.