What’s New for Biologics | FDA

What’s New for Biologics | FDA

June 11, 2019 Approval Letter - Quadracel 6/12/2019 TRG Rapid Inquiry Program (TRIP) 6/12/2019

6/13/2019	Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry
6/13/2019	CBER-Regulated Products: Current Shortages Information on APLISOL
6/12/2019	June 11, 2019 Approval Letter - Quadracel
6/12/2019	TRG Rapid Inquiry Program (TRIP)
6/11/2019	June 11, 2019 Approval Letter - Pentacel
6/10/2019	BK190351 - ALYX Component Collection System
6/10/2019	BK190324 - VISTASEAL Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible)
6/7/2019	June 7, 2019 Approval Letter - RAGWITEK
6/3/2019	Complete List of Currently Approved NDA and ANDA Application Submissions Updated as of 5/31/2019
6/3/2019	Complete List of Currently Approved Premarket Applications (PMAs) Updated as of 5/31/2019