What’s New for Biologics | FDA

What’s New for Biologics | FDA

Regulatory Harmonization and Convergence Update Posted: 8/9/2019 July 18, 2019 Summary Basis for Regulatory Action - Alinity s Anti-HBc Posted: 8/9/2019 Influenza Vaccine for the 2019-2020 Season Update Posted: 8/9/2019

8/9/2019	Regulatory Harmonization and Convergence Update
8/9/2019	July 18, 2019 Summary Basis for Regulatory Action - Alinity s Anti-HBc
8/9/2019	Influenza Vaccine for the 2019-2020 Season Update
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
7/19/2019	Workshop Agenda for the Identification and Use of Biomarkers to Advance Development in Preventative Vaccines
7/19/2019	CBER-Regulated Products: Current Shortages Information on BCG Vaccine
7/18/2019	CBER Vacancy: Senior Staff Fellow - Allergic Diseases (Biologist), RG-0401
7/17/2019	CBER Vacancy: Senior Staff Fellow (Research/Review Scientist) – Viral Vaccines (Biologist), RG-0401
7/17/2019	Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop
7/17/2019	July 12, 2019 Approval Letter - ALPROLIX
7/16/2019	Clinical Investigator Inspection List Updated through 6/30/2019
7/16/2019	July 15, 2019 Approval Letter - Flumist
7/15/2019	2019 Biological License Application Approvals Updated as of 6/30/2019
7/15/2019	2019 Biological Device Application Approvals Updated as of 6/30/2019
7/15/2019	July 8, 2019 Summary Basis for Regulatory Action - Alinity s Anti-HCV
7/12/2019	Cell analysis technique identifies subpopulations of stimulated mesenchymal stromal cells with in vitro immunosuppressive activity
7/12/2019	Senior Staff Fellow/Visiting Scientist – Molecular Virologist (Biologist), Rg-0401
7/12/2019	ORTHO VISION® Analyzer
7/11/2019	July 8, 2019 Approval Letter - ORTHO Sera
7/10/2019	MTS™ Buffered Gel Card
7/10/2019	July 9, 2019 Approval Letter - Alinity s Anti-HCV
7/10/2019	July 8, 2019 Approval Letter - MTS Anti- IgG Card