Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry  Food and Drug Administration (FDA) Final
FDA Export Certification: Guidance for Industry  Food and Drug Administration (FDA) Final
FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry  Food and Drug Administration (FDA) Final
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry  Food and Drug Administration (FDA) Final
Format and Content of the Microbiology Section of an Application*: Guidance for Industry  Food and Drug Administration (FDA) Final
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.