What’s New for Biologics | FDA

What’s New for Biologics | FDA

July 23, 2019 Approval Letter - Alinity s HIV Ag/Ab Combo Reagent Kit

Posted: 7/24/2019

Biological Product Deviations; Updated the CDER address for submitting BPDRs

Posted: 7/24/2019

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	Influenza Vaccine for the 2019-2020 Season Update
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	Influenza Vaccine for the 2019-2020 Season
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
6/28/2019	December 31, 2018 Approval Letter - ANDEXXA
6/27/2019	CBER Advanced Technologies Program
6/27/2019	June 26, 2019 Approval Letter - Alinity's HTLV I/II
6/27/2019	Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review/CBER; Public Workshop Draft Agenda
6/26/2019	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2019
6/26/2019	SENIOR STAFF FELLOW – Glycoconjugate Vaccines (Chemist), RG-1320
6/26/2019	Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement
6/24/2019	BK190337 - Galileo NEO