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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.

9/20/2021 September 20, 2021 Approval Letter - CANDIN
9/20/2021 September 16, 2021 Untitled Letter - Genesis Medical Center
9/17/2021 2021 Biological License Application Approvals
9/17/2021 2021 Biological Device Application Approvals
9/16/2021 September 15, 2021 Approval Letter - Berinert
9/15/2021 BK210605 - Galileo NEO
9/15/2021 BK210600 - NEO Iris
9/15/2021 Influenza Vaccine for the 2021-2022 Season
9/15/2021 Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products
9/15/2021 Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set
9/15/2021 eSubmitter Application History
9/13/2021 Blood Products Advisory Committee November 4, 2021 Meeting Announcement
9/8/2021 Influenza Vaccine for the 2021-2022 Season
9/7/2021 September 3, 2021 Approval Letter - Blood Grouping Reagent Anti-Jka, Anti-Jkb
9/2/2021 Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement
9/2/2021 August 13, 2021 Summary Basis for Regulatory Action - TICOVAC
9/2/2021 Influenza Vaccine for the 2021-2022 Season
9/1/2021 Complete List of Licensed Products and Establishments
9/1/2021 Complete List of Substantially Equivalent 510(k) Device Applications
9/1/2021 Complete List of Currently Approved Premarket Approvals (PMAs)
9/1/2021 Complete List of Currently Approved NDA and ANDA Application Submissions
8/27/2021 August 25, 2021 Approval Letter - CEPROTIN
8/27/2021 Preguntas y respuestas sobre Comirnaty (Vacuna de ARNm contra el COVID-19)
8/27/2021 Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement
8/26/2021 Influenza Vaccine for the 2021-2022 Season
8/24/2021 August 23, 2021 Summary Basis for Regulatory Action - Comirnaty
8/23/2021 August 23, 2021 Approval Letter - Comirnaty
8/20/2021 Notifying FDA of Fatalities Related to Blood Collection or Transfusion; Guidance for Industry

 



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