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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.

12/1/2020 User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
11/30/2020 November 25, 2020 Approval Order - LIAISON XL MUREX HIV Ab/Ag HT and Control HIV Ab/Ag HT
11/25/2020 Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement
11/25/2020 November 24, 2020 Approval Order - INTERCEPT Blood System for Plasma
11/25/2020 Influenza Vaccine for the 2020-2021 Season
11/21/2020 Expiration Date Extension for 42 Cutaquig [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] Lots manufactured in 2019 and 2020
11/20/2020 BK200520 - DiaSpect system
11/20/2020 BK200526 - National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS)
11/20/2020 Emergency Use Authorization for Vaccines Explained
11/20/2020 Vaccine Development – 101
11/18/2020 Influenza Vaccine for the 2020-2021 Season
11/18/2020 Getting Started with ICSR Submission to FDA’s electronic Vaccine Adverse Event Reporting System (eVAERS)
11/18/2020 CBER Vaccine ICSR Implementation
11/17/2020 Coronavirus (COVID-19) | CBER-Regulated Biologics
11/17/2020 2020 Biological Device Application Approvals
11/17/2020 2020 Biological License Application Supplement Noteworthy Approvals
11/16/2020 Recommendations for Investigational COVID-19 Convalescent Plasma
11/16/2020 Investigational COVID-19 Convalescent Plasma; Guidance for Industry
11/12/2020 eSubmitter Application History
11/12/2020 BK200513 - e-Delphyn LIS Donor
11/12/2020 November 10, 2020 Untitled Letter - Regenerative Cell Institute LLC
11/10/2020 November 9, 2020 Approval Letter - TUBERSOL
11/9/2020 BK200517- GDS (Grifols Donation System) V2.0
11/9/2020 BK200515 - e-Delphyn Donor version 11.0.0.1
11/6/2020 Genome Editing and Advanced Manufacturing of Hematopoietic Stem Cell-Based Therapeutics
11/5/2020 Influenza Vaccine for the 2020-2021 Season
11/4/2020 October 29, 2020 Approval Letter - ALPROLIX
11/2/2020 Complete List of Licensed Products and Establishments
11/2/2020 Complete List of Substantially Equivalent 510(k) Device Applications
11/2/2020 Complete List of Currently Approved Premarket Approvals (PMAs)
11/2/2020 Complete List of Currently Approved NDA and ANDA Application Submissions
11/2/2020 October 30, 2020 Untitled Letter - Young Foundational Health Center, LLC
10/30/2020 Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs
10/30/2020 Influenza Vaccine for the 2020-2021 Season
10/28/2020 October 28, 2020 Approval Letter - Fluad and Fluad Quadrivalent
10/27/2020 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
10/27/2020 October 27, 2020 Approval Letter - VAXELIS
10/27/2020 Gastrointestinal Viruses: Understanding Diversity and Immune Responses to Inform Vaccine Design
10/26/2020 October 23, 2020 Approval Letter - VAQTA
10/23/2020 BK200476 - PK CMV-PA System
10/22/2020 BK200512 - Regulated Software Application (RSA), Version 2.0
10/22/2020 Summary of Safety and Effectiveness - VioOne HIV Profile Supplemental Assay
10/22/2020 October 21, 2020 Approval Letter - Blood Grouping Reagent Anti-e
10/21/2020 Influenza Vaccine for the 2020-2021 Season
10/20/2020 October 19, 2020 Approval Order - VioOne HIV Profile Supplemental Assay


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