What’s New for Biologics | FDA

What’s New for Biologics | FDA

Posted: 6/18/2020

• eSubmitter Application History

6/19/2020	BK190356 - PrepaCyte-CB Processing System
6/18/2020	eSubmitter Application History
6/16/2020	BK200474 - NEO Iris
6/16/2020	June 12, 2020 Approval Letter - Referencells
6/16/2020	June 12, 2020 Approval Letter - Panoscreen and Panoscreen Extend
6/16/2020	2020 Biological License Application Supplement Noteworthy Approvals
6/16/2020	2020 Biological Device Application Approvals
6/16/2020	CBER Vaccine ICSR Implementation
6/16/2020	CBER Vaccine ICSR (Legacy) Implementation
6/16/2020	Getting Started with ICSR Submission of FDA's electronic Vaccines Adverse Event Reporting System (eVAERS)
6/16/2020	Electronic Submission of Postmarket Safety Reports
6/15/2020	BK200479 - WellSky Blood - Emergency Issue 2020 R1
6/15/2020	June 12, 2020 Approval Letter - Gardasil 9
6/12/2020	Regenerative Medicine Fellowship under the Service Fellowship Program for CBER
6/11/2020	Assessing Immunogenicity of Products for Gene Therapy and T cell Therapy
6/11/2020	Investigating the Effects of Cell-Materials Interactions on the Safety and Effectiveness of Cell-Based Products
6/11/2020	June 9, 2020 Approval Letter - Kedbumin
6/11/2020	BK200475 - ALYX Component Collection System
6/11/2020	BK200482 - Blood Product Administration Module Version 3-2020
6/9/2020	BK190393 - Aeon CPKit
6/5/2020	New Approaches to the Development and Evaluation of Human Cytomegalovirus (HCMV) Vaccines
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