Learning Tracks

ANDA Deficiency Trends: Common Issues to Improve ANDA Submission Quality

Monday, October 21, 2024

10:45 a.m. - 12:00 p.m.

Grand Ballroom A-E

In this session, FDA will provide an overview of ANDA assessment cycle actions and major deficiency trends. FDA will share common deficiencies issued by assessment disciplines, areas to improve ANDA submission quality, and resources available to industry. Industry will present their experience on frequently received comments and changes in data requests and offer their perspectives on review consistency and their experiences with late-cycle IRs and CRs in generic drug applications.