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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.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry  Food and Drug Administration (FDA) Final
Development and Use of Risk Minimization Action Plans: Guidance for Industry  Food and Drug Administration (FDA) Final
Development of Anti-Infective Drug Products for the Pediatric Population : Guidance for Industry  Food and Drug Administration (FDA) Final
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry  Food and Drug Administration (FDA) Final
Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry  Food and Drug Administration (FDA) Final
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.