GDUFA Implementation Quarterly Meetings between FDA and Industry

FDA and representatives of the generic drug industry meet quarterly to discuss topics related to the implementation of GDUFA.  Minutes from these meetings are posted on this page.

FDA - Industry Quarterly Meetings FY 2023

• Meeting Minutes - February 6, 2023 (PDF - 123 KB)
• Meeting Minutes - November 16, 2022 (PDF - 128 KB)

FDA - Industry Quarterly Meetings FY 2020

• Meeting Minutes - January 21, 2020 (PDF - 28 KB)

FDA - Industry Quarterly Meetings FY 2019

• Meeting Minutes - October 15, 2019 (PDF - 23 KB)
• Meeting Minutes - July 16, 2019 (PDF - 29 KB)
• Meeting Minutes - April 16, 2019 (PDF - 29 KB)
• Meeting Minutes – January 10, 2019 (PDF - 40 KB)

FDA - Industry Quarterly Meetings FY 2018

• Meeting Minutes – July 18, 2018 (PDF - 75 KB)
• Meeting Minutes -- April 10, 2018 (PDF - 61 KB)
• Meeting Minutes – January 10, 2018 (PDF - 40 KB)

FDA - Industry Quarterly Meetings FY 2017

• Meeting Minutes - September 21, 2017 (PDF - 35 KB)
• Meeting Minutes - June 29, 2017 (PDF - 22 KB)
• Meeting Minutes - March 31, 2017 (PDF - 32 KB)

2013-2015 meeting materials are in the FDA Archive