What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 06/03/2020

OraQuick In-Home HIV Test Fact Sheet

6/3/2020	OraQuick In-Home HIV Test Fact Sheet
6/1/2020	Complete List of Licensed Products and Establishments
6/1/2020	Complete List of Substantially Equivalent 510(k) Device Applications
6/1/2020	Complete List of Currently Approved Premarket Approvals (PMAs)
6/1/2020	Complete List of Currently Approved NDA and ANDA Application Submissions
5/28/2020	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
5/27/2020	May 14, 2020 Approval Letter - CUTAQUIG
5/27/2020	May 18, 2020 Approval Letter - YESCARTA
5/22/2020	Identification of Targets for Development of Vaccines and Biological Therapies Against Gastrointestinal Pathogens
5/21/2020	BK200472 - BACT/ALERT BPA Culture Bottle; BACT/ALERT BPN Culture Bottle
5/21/2020	HCT/P Inspection Information
5/19/2020	Annual Summary for Fiscal Year 2019
5/19/2020	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
5/18/2020	2020 Biological License Application Approvals
5/18/2020	2020 Biological Device Application Approvals
5/14/2020	April 28, 2020 Untitled Letter - ValeoMD
5/14/2020	May 13, 2020 Approval Letter - FLUAD
5/14/2020	April 22, 2020 Summary Basis for Regulatory Action - MenQuadfi
5/13/2020	May 12, 2020 Approval Letter - Flublok
5/12/2020	May 11, 2020 Untitled Letter - Sparrow Health & Performance, LLC
5/12/2020	Transcript for the Facilitating End-to-End Development of Individualized Therapeutics Public Workshop
5/12/2020	May 11, 2020 Approval Letter - Anti - M (Murine Monoclonal IgG) STN#125308-56
5/12/2020	eSubmitter Application History
5/11/2020	Updated Information for Blood Establishments Regarding the Novel Coronavirus (COVID-19) Outbreak
5/11/2020	CBER-Regulated Products: Resolved Shortages
5/10/2020	May 7, 2020 Approval Letter - Blood Grouping Reagent Anti-e P3GD512 + MS16 + MS21 + MS63
5/8/2020	BK200478 - Aurora Xi Plasmapheresis System
5/8/2020	BK190313 - PK System Control
5/8/2020	May 7, 2020 Approval Letter - Reagent Red Blood Cells A1 Cells / B Cells
5/8/2020	May 7, 2020 Approval Letter - Blood Grouping Regents Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-D (PK 1), Anti-D (PK 2), Anti-E, Anti-e, Anti-C, Anti-c, and Anti-K
5/8/2020	BK180292 - PK7400 Automated Microplate System
5/7/2020	May 5, 2020 Approval Letter - VAXELIS
5/6/2020	April 27, 2020 Untitled Letter - Henry N. Small, MD, PA
5/6/2020	May 6, 2020 Approval Letter - HEPLISAV-B
5/5/2020	Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
5/4/2020	May 1, 2020 Approval Order - INTERCEPT Blood System for Plasma
5/4/2020	April 28, 2020 Untitled Letter - BrioMD