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
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act  Food and Drug Administration (FDA) Proposed
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption  Food and Drug Administration (FDA) Proposed
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions  Food and Drug Administration (FDA) Proposed
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4742 documents.