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
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part X Appendices  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program for Individual and Small Group Physician Practices  Office of Inspector General (OIG) Proposed
Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees  Office of Inspector General (OIG) Proposed
Malik: Test  Centers for Medicare & Medicaid Services (CMS) Proposed
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Proposed
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49450 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.