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
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned  Food and Drug Administration (FDA) Proposed
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3298 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.