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
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Orange Book Questions and Answers Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Review and Update of Device Establishment Inspection Processes and Standards: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Draft Instructions for Completing the Prescription Drug Plan Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) Proposed
This Guidance Portal contains 49167 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.