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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
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Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed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Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed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
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Clinical Investigator Administrative Actions - Disqualification: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors  Food and Drug Administration (FDA) Final
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