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 ascending Issue Date
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  Food and Drug Administration (FDA) Proposed
BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE  Food and Drug Administration (FDA) Proposed
Bispecific Antibody Development Programs 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
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies  Food and Drug Administration (FDA) Proposed
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50115 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.