What’s New for Biologics

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