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
CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease  Food and Drug Administration (FDA) Proposed
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs  Food and Drug Administration (FDA) Proposed
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards,…  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5570 documents.