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
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 540.750 Draft Revision - Use of The Seafood List to Determine Acceptable Seafood Names  Food and Drug Administration (FDA) Proposed
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs   Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)  Food and Drug Administration (FDA) Proposed
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information  Food and Drug Administration (FDA) Proposed
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 48713 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.