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  4. How Drugs are Developed and Approved
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  6. Abbreviated New Drug Application (ANDA)
  7. GDUFA Implementation Quarterly Meetings between FDA and Industry
  1. Abbreviated New Drug Application (ANDA)

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 2024

FDA - Industry Quarterly Meetings FY 2023

FDA - Industry Quarterly Meetings FY 2020

FDA - Industry Quarterly Meetings FY 2019

FDA - Industry Quarterly Meetings FY 2018

FDA - Industry Quarterly Meetings FY 2017

2013-2015 meeting materials are in the FDA Archive
 
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