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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
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
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry  Food and Drug Administration (FDA) Final
Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry  Food and Drug Administration (FDA) Final
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.