What’s New for Biologics | FDA

What’s New for Biologics | FDA

Workshop Draft Agenda for the Identification and Use of Biomarkers to Advance Development in Preventative Vaccines; Update

Posted: 8/1/2019

Luciferase Immunoprecipitation System (LIPS) assay is a rapid, simple, and sensitive test to detect antibody response to respiratory syncytial virus

Posted: 8/1/2019

Influenza Vaccine for the 2019-2020 Season; Update

Posted: 8/1/2019

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
8/1/2019	Influenza Vaccine for the 2019-2020 Season Update
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
7/5/2019	Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year Data as of June 30, 2019
7/5/2019	July 3, 2019 Approval Letter - XEMBIFY
7/5/2019	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 6/30/2019
7/5/2019	Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 6/30/2019
7/5/2019	Complete List of Substantially Equivalent 510(k) Device Applications Updated as of 6/30/2019
7/5/2019	Complete List of Licensed Products and Establishments Updated as of 6/30/2019
7/3/2019	July 2, 2019 Approval Letter - Flucelvax
7/3/2019	July 2, 2019 Approval Letter - Fluad
7/3/2019	July 2, 2019 Approval Letter - Afluria
7/3/2019	July 2, 2019 Approval Letter - Flublok
7/3/2019	July 2, 2019 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose
7/3/2019	July 2, 2019 Approval Letter - FluLaval