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Last Updated: October 3, 2026
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CDER's Jonathan Resnick covers points to consider when preparing an eCTD submission and sending to FDA. Learn more at ... Elizabeth Bearr from CDER's Office of Office of CDER Office of Pharmaceutical Quality's Robert T. Berendt covers key considerations during CDER's Vincent Sansone provides an overview of GDUFA II goal dates and how they are applied to original applications, ... Presenters Khanna, Bearr, Shen, Smith, Munshi, Patel, Mbi, Sansone, Julia Lee, and Andrea Bautista answer audience questions. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA Donal Parks, director of CDER's Division of User Fee Management and Budget Formulation in the Office of Management (OM), ...
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