GDUFA Implementation: Bi-Annual Industry Regulatory Science Work Group Meeting

FDA and representatives of the generic drug industry meet bi-annually to discuss current and emerging regulatory science challenges and concerns. Minutes from these meetings are posted on this page.

FDA - Industry Regulatory Science Work Group Meeting FY 2024

• Meeting Minutes - August 28, 2024 (PDF - 155 KB)

FDA - Industry Regulatory Science Work Group Meeting FY 2023

• Meeting Minutes – August 30, 2023 (PDF - 163 KB)
• Meeting Minutes – November 17, 2023 (PDF - 154 KB)

FDA - Industry Regulatory Science Work Group Meeting FY 2022

• Meeting Minutes – March 23, 2022 (PDF - 211 KB)
• Meeting Minutes – December 8, 2022 (PDF - 155 KB)

FDA - Industry Regulatory Science Work Group Meeting FY 2021

• Meeting Minutes – March 12, 2021 (PDF - 133 KB)
• Meeting Minutes – September 24, 2021 (PDF - 157 KB)

FDA - Industry Regulatory Science Work Group Meeting FY 2020

• Meeting Minutes – February 10, 2020 (PDF - 103 KB)
• Meeting Minutes – October 6, 2020 (PDF - 96 KB)

FDA – Industry Regulatory Science Work Group Meetings FY 2019

• Meeting Minutes – September 17, 2019 (PDF - 100 KB) 
• Meeting Minutes – February 25, 2019 (PDF - 100 KB) 

FDA - Industry Regulatory Science Work Group Meetings FY 2018

• Meeting Minutes - November 1, 2018 (PDF - 107 KB)
• Meeting Minutes – April 10, 2018 (PDF - 75 KB)