1998-2014 reports are in the FDA Archive

Efficacy Supplement Reports

• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2020
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2019
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2018
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2017
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2016
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2015

Summary Level Review Report

• Report of Summary Level Review Under Section 3031 of 21st Century Cures - 2017 to 2020 (PDF - 58 KB)