What’s New for Biologics | FDA

What’s New for Biologics | FDA

October 25, 2019 Approval Letter - IMOVAX

Posted: 10/28/2019

2019 Biological License Application Supplement Noteworthy Approvals

Posted: 10/28/2019

2019 Biological License Application Approvals

Posted: 10/28/2019

2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

Posted: 10/28/2019

2019 Biological Device Application Approvals

Posted: 10/28/2019

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	Influenza Vaccine for the 2019-2020 Season