Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

Search HHS Guidance Documents

 

Filter Guidance Documents by ...

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Qualified Infectious Disease Product Designation Questions and Answers  Food and Drug Administration (FDA) Proposed
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors  Food and Drug Administration (FDA) Proposed
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
EDPPPS Proposed Edit Comments Letter V2 - December 2011  Centers for Medicare & Medicaid Services (CMS) Proposed
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Draft Guidance for Industry and FDA Staff   Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49012 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CDC

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.