What’s New for Biologics | FDA

What’s New for Biologics | FDA

FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions

Posted: 11/25/2019

11/25/2019	FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions
11/22/2019	November 20, 2019 Untitled Letter - RichSource Stem Cells, Inc.
11/21/2019	Influenza Vaccine for the 2019-2020 Season
11/18/2019	2019 Biological Device Application Approvals
11/18/2019	2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
11/18/2019	November 7, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant)
11/18/2019	November 7, 2019 - Anti-Fya (Murine Monoclonal) (Recombinant)
11/15/2019	SOPP 8116: Use of Electronic Signatures for Regulatory Documents
11/14/2019	Influenza Vaccine for the 2019-2020 Season
11/13/2019	November 12, 2019 Approval Letter - Rotarix
11/13/2019	CBER-Regulated Products: Current Shortages
11/12/2019	BK190349 - RD2 System
11/7/2019	BK190406 - Arthrex Double Syringe (ACP) kit
11/7/2019	BK180296 - Fidia PRP Kit
11/6/2019	Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Discussion Topics
11/6/2019	November 6, 2019 Approval Letter - INFANRIX
11/6/2019	November 6, 2019 Approval Letter - PEDIARIX
11/6/2019	November 6, 2019 Approval Letter - KINRIX
11/5/2019	November 5, 2019 Grant Order - Sentosa SQ HIV-1 Genotyping Assay
11/5/2019	Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS)
11/4/2019	November 4, 2019 Approval Letter - Fluzone High-Dose Quadrivalent
11/4/2019	SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products
11/4/2019	Complete List of Currently Approved NDA and ANDA Application Submissions
11/4/2019	Complete List of Currently Approved Premarket Applications (PMAs)
11/4/2019	Complete List of Substantially Equivalent 510(k) Device Applications
11/4/2019	Complete List of Licensed Products and Establishments
10/31/2019	Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile - Agenda
10/29/2019	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
10/28/2019	October 25, 2019 Approval Letter - IMOVAX
10/28/2019	2019 Biological License Application Supplement Noteworthy Approvals
10/28/2019	2019 Biological License Application Approvals
10/28/2019	2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
10/28/2019	2019 Biological Device Application Approvals
10/25/2019	October 25, 2019 Approval Letter - ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION, USP
10/25/2019	Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile - Agenda
10/25/2019	October 24, 2019 Approval Letter - BEXSERO
10/24/2019	CBER-Regulated Products: Resolved Shortages