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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs  Food and Drug Administration (FDA) Proposed
Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials: Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed
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Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards,…  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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