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  1. Vaccines, Blood & Biologics

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

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.

Date Title
8/23/2019 Influenza Vaccine for the 2019-2020 Season
Update
8/22/2019 Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Transcript for July 15, 2019
8/22/2019 Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Transcript for July 16, 2019
8/22/2019 CBER-Regulated Products: Current Shortages
Information on Imogam
8/22/2019 CBER-Regulated Products: Current Shortages
Update on Gammaplex
8/20/2019 August 14, 2019 Summary Basis for Regulatory Action - Alinity s Chagas
8/16/2019 August 15, 2019 Approval Letter - Alinity s Chagas
8/16/2019 Summary Basis for Regulatory Action - Blood Grouping Reagent, Anti -A (Murine Monoclonal) (FFMU) STN 125669 & 125680
8/15/2019 CBER Vacancy: Senior Staff Fellow - Microbial Pathogenesis
8/15/2019 Developing Alpha-1 Antitrypsin Therapeutics; Public Workshop
8/13/2019 August 12, 2019 Approval Letter - Blood Grouping Reagent, Anti-A (Murine Monoclonal) STN# 125449/44
8/13/2019 August 12, 2019 Approval Letter - Blood Grouping Reagent, Anti-A (Murine Monoclonal) (FFMU) STN# 125669
8/13/2019 August 12, 2019 Approval Letter - Blood Grouping Reagent, Anti-A (Murine Monoclonal) (FFMU) STN# 125680
8/12/2019 Information About Immune Globulin (Human) Product Shortage
8/9/2019 Regulatory Harmonization and Convergence
Update
8/9/2019 July 18, 2019 Summary Basis for Regulatory Action - Alinity s Anti-HBc
8/7/2019 Annual Summary for Fiscal Year 2018
8/6/2019 BK180301 - PK7400 TP HA Controls and PK7400 TP HA Reagent
8/5/2019 August 2, 2019 - Approval Letter Alinity s Anti-HBc
8/2/2019 Complete List of Currently Approved NDA and ANDA Application Submissions
Updated as of 7/31/2019
8/2/2019 Complete List of Currently Approved Premarket Applications (PMAs)
Updated as of 7/31/2019
8/2/2019 Complete List of Substantially Equivalent 510(k) Device Applications
Updated as of 7/31/2019
8/2/2019 Complete List of Licensed Products and Establishments
Updated as of 7/31/2019
8/1/2019 Workshop Draft Agenda for the Identification and Use of Biomarkers to Advance Development in Preventative Vaccines
Update
8/1/2019 Luciferase Immunoprecipitation System (LIPS) assay is a rapid, simple, and sensitive test to detect antibody response to respiratory syncytial virus
7/31/2019 July 29, 2019 Approval Order - HIV Combo Reagent Pack-HIV Combo Calibrator
7/29/2019 BK190368 - Aurora Plasmapheresis System, Software Version 2.1
7/24/2019 July 23, 2019 Approval Letter - Alinity s HIV Ag/Ab Combo Reagent Kit
7/24/2019 Biological Product Deviations
Updated the CDER address for submitting BPDRs
7/24/2019 July 3, 2019 Summary Basis for Regulatory Action - XEMBIFY
7/23/2019 Drug Recall: Kogenate FS antihemophilic factor (recombinant) 2000 IU
7/23/2019 BK190363 - Timestrip Blood Temp 10 (BT10)


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