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 ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Psychedelic Drugs: Considerations for Clinical Investigations  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
Potency Assurance for Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics  Food and Drug Administration (FDA) Proposed
Pulmonary Tuberculosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Dry Eye: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3359 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.