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
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process  Food and Drug Administration (FDA) Final
CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs  Food and Drug Administration (FDA) Final
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use  Food and Drug Administration (FDA) Proposed
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles  Food and Drug Administration (FDA) Proposed
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications  Food and Drug Administration (FDA) Final
Considerations in Demonstrating Interchangeability With a Reference Product: Update  Food and Drug Administration (FDA) Proposed
CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting  Food and Drug Administration (FDA) Final
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry  Food and Drug Administration (FDA) Final
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.