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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.

8/19/2022 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium
8/18/2022 Key Facts About Vaccines to Prevent Monkeypox Disease
8/17/2022 August 17, 2022 Approval Letter - ZYNTEGLO
8/17/2022 Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement
8/15/2022 PREA Non-Compliance Letters
8/12/2022 User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
8/12/2022 Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
8/11/2022 August 10, 2022 Approval Letter - Octagam 5%
8/10/2022 August 5, 2022 Approval Letter - ZOLGENSMA
8/10/2022 Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting Announcement
8/4/2022 OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls
8/1/2022 Complete List of Licensed Products and Establishments
8/1/2022 Complete List of Substantially Equivalent 510(k) Device Applications
8/1/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
8/1/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
8/1/2022 Changes to Disposable Manufacturing Materials: Questions and Answers; Guidance for Industry
7/28/2022 BK220669 - NEO Iris
7/28/2022 BK220670 - Galileo NEO
7/28/2022 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120(a)
7/28/2022 July 14, 2022 Summary Basis for Regulatory Action -Alinity s Anti-HCV II assay
7/27/2022 July 27, 2022 Approval Letter - FluMist
7/27/2022 July 8, 2022 Clinical Review Memo - COMIRNATY
7/27/2022 Statistical Review - COMIRNATY
7/27/2022 July 27, 2022 Approval Letter - ActHIB
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagents (Monoclonal) Anti-S, Anti-s and Anti-Fya (IgG)
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagent, Anti-k (Monoclonal)
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagent, Anti-Fyb (Monoclonal)
7/25/2022 CBER Vacancy: Principal Investigator - Biomedical Engineering
7/22/2022 July 21, 2022 Approval Letter - DAPTACEL
7/22/2022 Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
7/22/2022 July 21, 2022 Approval Letter - Pentacel
7/22/2022 July 21, 2022 Approval Letter - Quadracel
7/21/2022 Clinical Investigator Status (Biologics)

 



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