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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.

6/23/2022 CBER Vacancy: Staff Fellow/Visiting Associate - Pharmacology/Toxicology Reviewer
6/23/2022 June 21, 2022 Approval Letter - VISTASEAL
6/23/2022 Interactions with Office of Tissues and Advanced Therapies
6/22/2022 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022
6/22/2022 Federal Register Notice: Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program
6/21/2022 2022 Biological License Application Approvals
6/21/2022 2022 Biological License Application Supplement Noteworthy Approvals
6/21/2022 2022 Biological Device Application Approvals
6/21/2022 June 17, 2022 Approval Letter - VAXNEUVANCE
6/17/2022 June 16, 2022 Approval Letter - MenQuadfi
6/15/2022 June 15, 2022 Approval Letter - Procleix Ultrio Elite Assay
6/15/2022 Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry
6/13/2022 Expiration Date Extension for 6 ASCENIV [Immune Globulin Intravenous, Human-slra, 10% Liquid] Lots manufactured in 2019 - 2020
6/10/2022 eSubmitter Download and Installation
6/10/2022 BK210653 - ORTHO Daily QC Simulated Whole Blood Quality Control Kit
6/9/2022 Coronavirus (COVID-19) | CBER-Regulated Biologics
6/9/2022 Letter to Sponsors, Applicants and Regulated Entities on COVID-19
6/9/2022 eSubmitter Application History
6/9/2022 June 8, 2022 Approval Letter – LUXTURNA
6/8/2022 May17, 2021 Summary Basis for Regulatory Action - Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal
6/8/2022 CBER-Regulated Products: Resolved Shortages
6/7/2022 June 3, 2022 Approval Letter – Anti-Human Globulin and Blood Grouping Reagent (BL 103461/5118, et.al)
6/6/2022 June 2, 2022 Approval Letter - Blood Grouping Reagents, Anti-Ds ((Monoclonal) (IgM), (Monoclonal) (IgM Blend) and (Monoclonal Blend))
6/6/2022 May 17, 2022 Summary Basis for Regulatory Action - DG Gel 8 Direct Coombs
6/3/2022 June 3, 2022 Approval Letter – PRIORIX
6/3/2022 June 2, 2022 Approval Letter - IPOL
6/2/2022 Complete List of Licensed Products and Establishments
6/2/2022 Complete List of Substantially Equivalent 510(k) Device Applications
6/2/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
6/2/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
5/31/2022 May 27, 2022 Approval Letter - KYMRIAH
5/31/2022 Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement
5/26/2022 Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement
5/26/2022 Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement
5/26/2022 Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Announcement
5/26/2022 Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
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

 



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