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  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

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

5/26/2022 BK210631 - Sysmex XN-10 Automated Hematology Analyzer
5/26/2022 May 20, 2022 Approval Letter - ANDEXXA
5/25/2022 Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103
5/24/2022 May 20, 2022 Approval Letter - Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal
5/24/2022 May 20, 2022 Approval Letter - Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine Monoclonal
5/24/2022 OTAT Learn
5/24/2022 May 20, 2022 Approval Letter - DG Gel 8 Direct Coombs (Anti-IgG, -C3d)
5/24/2022 May 20, 2022 Approval Letter - DG Gel 8 Direct Coombs (Anti-C3d)
5/23/2022 Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry
5/23/2022 Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Draft Guidance for Industry
5/23/2022 Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
5/20/2022 CBER Vacancy: Staff Fellow/Visiting Associate - Biologist
5/19/2022 Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338
5/19/2022 Regulatory Education for Industry (REdI) Annual Conference 2022
5/16/2022 May 12, 2022 Approval Letter - RYPLAZIM
5/16/2022 2022 Biological License Application Supplement Noteworthy Approvals
5/16/2022 2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
5/13/2022 HCT/P Inspections Performed in Fiscal Years 2017-2021
5/12/2022 Biologics Procedures (SOPPs) - Section 8300: Master Files
5/12/2022 May 11, 2022 Approval Letter - Flublok Quadrivalent
5/11/2022 Expiration Date Extension for 120 BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] Lots manufactured in 2020 - 2022
5/9/2022 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022
5/6/2022 eSubmitter Application History
5/6/2022 Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
5/3/2022 Complete List of Licensed Products and Establishments
5/3/2022 Complete List of Substantially Equivalent 510(k) Device Applications
5/3/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
5/3/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
4/29/2022 Regulatory Education for Industry (REdI) Annual Conference 2022
4/27/2022 April 25, 2022 Approval Letter - ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP - BA 125750

 



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