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 Sort descending Guidance Status Issue Date
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry  Food and Drug Administration (FDA) Final
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing: Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007: Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry  Food and Drug Administration (FDA) Final
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 49871 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.