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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
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
Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for Industry  Food and Drug Administration (FDA) Final
Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry  Food and Drug Administration (FDA) Final
Cellular Therapy for Cardiac Disease: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.