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 Issue Date Sort ascending
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Accelerated Approval – Expedited Program for Serious Conditions  Food and Drug Administration (FDA) Proposed
Protecting Medicaid Beneficiaries Against Impermissible Fraud and Abuse Sanctions (SMD 24-005) [RESCINDED ON MAY 1, 2025]  Centers for Medicare & Medicaid Services (CMS) Final
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability  Food and Drug Administration (FDA) Final
Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects  Food and Drug Administration (FDA) Proposed
Basic Requirements for Conducting Ex Parte Renewals of Medicaid and CHIP Eligibility  Centers for Medicare & Medicaid Services (CMS) Final
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3312 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.