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
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels  Food and Drug Administration (FDA) Proposed
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Insanitary Conditions at Compounding Facilities Guidance for Industry  Food and Drug Administration (FDA) Proposed
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations  Food and Drug Administration (FDA) Proposed
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans  Food and Drug Administration (FDA) Proposed
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49616 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.