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
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs  Food and Drug Administration (FDA) Proposed
Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products: Guidance for Industry:  Food and Drug Administration (FDA) Final
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance for Industry; Availability  Food and Drug Administration (FDA) Final
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases: Guidance for Industry; Availability  Food and Drug Administration (FDA) Final
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Specifications Document  Food and Drug Administration (FDA) Final
Qualified Infectious Disease Product Designation Questions and Answers: Guidance for Industy  Food and Drug Administration (FDA) Final
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed
Frequently Asked Questions - IRB Registration: Guidance for Institutional Review Boards (IRBs)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.