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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
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
Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications: Guidance for Industry  Food and Drug Administration (FDA) Final
For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for…  Food and Drug Administration (FDA) Final
General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases: Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry  Food and Drug Administration (FDA) Final
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for…  Food and Drug Administration (FDA) Final
"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.