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 Sort ascending Issue Date
Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy  Food and Drug Administration (FDA) Proposed
ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs  Food and Drug Administration (FDA) Proposed
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50235 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.