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
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
2022 Key Dates Table   Centers for Medicare & Medicaid Services (CMS) Proposed
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling  Food and Drug Administration (FDA) Proposed
CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)  Food and Drug Administration (FDA) Proposed
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  Food and Drug Administration (FDA) Proposed
eCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0  Food and Drug Administration (FDA) Proposed
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) 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.