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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.

7/5/2022 July 1, 2022 Approval Letter - FLUARIX QUADRIVALENT
7/5/2022 Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
7/5/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
7/5/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
7/5/2022 July 1, 2022 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
7/5/2022 July 1, 2022 Approval Letter - Afluria and Afluria Quadrivalent 
7/5/2022 July 1, 2022 Approval Letter - Flublok Quadrivalent
7/5/2022 July 1, 2022 Approval Letter - Flucelvax Quadrivalent 
7/5/2022 July 1, 2022 Approval Letter - FLUAD QUADRIVALENT
7/5/2022 July 1, 2022 Approval Letter - FluLaval Quadrivalent
7/1/2022 Complete List of Licensed Products and Establishments
7/1/2022 Complete List of Substantially Equivalent 510(k) Device Applications
7/1/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
7/1/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
7/1/2022 June 24, 2022 Clinical Review Memorandum - BREYANZI
7/1/2022 June 24, 2022 Statistical Reviewer - BREYANZI
7/1/2022 Clinical Pharmacology Review - BREYANZI
7/1/2022 Memorandum Re: Fall 2022 COVID-19 Vaccine Strain Composition Selection Recommendation
6/30/2022 BK220724 - ORTHO Optix Reader
6/30/2022 Update: COVID-19 Vaccine Booster Composition
6/29/2022 June 3, 2022 Summary Basis for Regulatory Action - PRIORIX
6/28/2022 Biological Product Deviation Reports Annual Summaries
6/27/2022 June 24, 2022 Approval Letter - ORTHO Sera
6/27/2022 June 24, 2022 Approval Letter - BREYANZI
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

 



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