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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
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Final
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations  Food and Drug Administration (FDA) Final
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Exploratory IND Studies: Guidance for Industry, Investigators, and Reviewers  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.