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  1. News & Events (Biologics)

What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

Items related to biologics will be added to the top of the list as they are posted on the site.

10/14/2026Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry
10/14/2026Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry
10/09/2026October 7, 2026 Approval Letter - NUWIQ
10/08/2026Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
10/08/2026SOPP 8406: CBER Processing of PDUFA Application Payments
10/06/2026September 17, 2026 Summary Basis for Regulatory Action - FAYUVI
10/02/2026SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
10/02/2026Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
10/02/2026Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
10/02/2026Biological Product Deviation Reporting -- Blood Product Codes
09/30/2026September 29, 2026 Approval Letter - BIVIGAM
09/30/2026September 29, 2026 Approval Letter - ASCENIV
09/29/2026SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
09/29/2026SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes
09/28/2026September 25, 2026 Approval Letter - ROTARIX 
09/23/2026September 23, 2026 Approval Letter - ADZYNMA
09/21/2026SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
09/17/2026September 17, 2026 Approval Letter - FAYUVI
09/17/2026BK261388- INSTI® HIV-1/HIV-2 Antibody Test
09/17/2026Electronic Submission Template for Premarket Approval Applications (PMA); Draft Guidance for Industry and Food and Drug Administration Staff
09/17/2026September 15, 2026 Approval Letter - CPD, ADSOL Red Preservation Solution, (PL 146) and/or SEPACELL Filter
09/17/2026September 15, 2026 Approval Letter - ADSOL Red Cell Preservation Solution (PL 2209) CPD and ADSOL and/or SEPACELL in PL 2209
09/16/2026September 15, 2026 Approval Letter - THROMBIN-JMI LIQUID
09/16/2026September 15, 2026 Approval Order - OraQuick HIV Self-Test
09/16/2026Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry
09/14/2026Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Date: October 1, 2026
09/09/2026September 8, 2026 Approval Letter - THROMBIN-JMI
09/02/2026SOPP 8203: Administrative Processing and Review Management of Charging Requests (Cost Recovery Requests) for Investigational New Drugs and Investigational Devices
09/02/2026August 19, 2026 Summary Basis for Regulatory Action - GENGLYCOS


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