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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
Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors  Food and Drug Administration (FDA) Final
Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA Staff  Food and Drug Administration (FDA) Final
Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components: Guidance for FDA Reviewers  Food and Drug Administration (FDA) Final
Premarket Notification Submissions for Blood and Plasma Warmers: Guidance for FDA Reviewers  Food and Drug Administration (FDA) Final
Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices): Guidance for FDA Reviewers  Food and Drug Administration (FDA) Final
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors  Food and Drug Administration (FDA) Final
Release of ORA Laboratory Analytical Results to the Responsible Party: Guidance for Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles : Guidance for Government Public Health and Emergency Response Stakeholders  Food and Drug Administration (FDA) Final
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory: Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.