What’s New for Biologics | FDA

What’s New for Biologics | FDA

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
6/21/2019	June 19, 2019 Approval Letter - REFERENCELLS
6/20/2019	June 14, 2019 Summary Basis for Regulatory Action - Alinity s HBsAg and Alinty s HBsAg Confirmatory