What’s New for Biologics

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
8/22/2019	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	Influenza Vaccine for the 2019-2020 Season Update
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)
7/22/2019	BK190362 - Plasmalink Bottle with Locking Luer Adapter
7/22/2019	User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act Update