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Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15of27) Generic Drugs Forum 2018
Questions and Answers (5of28) Generic Drugs Forum – Apr. 3-4, 2019
Questions and Answers (15of28) Generic Drugs Forum – Apr. 3-4, 2019
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Questions and Answers (23of28) Generic Drugs Forum – Apr. 3-4, 2019
Questions and Answers (19of28) Generic Drugs Forum – Apr. 3-4, 2019
Pre-ANDA Meeting or Controlled Correspondence (4of28) Generic Drugs Forum – Apr. 3-4, 2019
Update on Technical Rejection Criteria for Study Data (14of28) Generic Drugs Forum – Apr. 3-4, 2019
Questions and Answers (11of28) Generic Drugs Forum – Apr. 3-4, 2019
Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019
Practical Tips on eCTD (13of28) Generic Drugs Forum – Apr. 3-4, 2019
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Last Updated: October 3, 2026
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Summary
Varun Vasudeva and Phuong (Aiden) Nguyen from CDER's Office of Presenters Larry Lee, Tony Huang, Vidya Pai answer audience questions. Learn more at ... Presenters Katherine Tyner, Christine Le, Bhagwant Rege, Kris Andre answer audience questions. Learn more at ... Kris Andre, Jonathan Resnick, and Ethan Chen answer audience questions. Learn more at ... Presenters Nusie Motlekar, Frank Holcombe, Om Anand, Hongbio Liao, and Victoria Keck answer audience questions. Presenters Aiden Nguyen, Varun Vasudeva, Dat Doan, Ke Ren and Julia Lee answer audience questions. Learn more at ... CDER Office of Business Informatics' Chao (Ethan) Chen presents recent updates of the FDA Study Data Technical Rejection ... Presenters Alicia Chen, Susan Levine, Elizabeth Friedman, Beth Goldstein and Orange Book Staff Supervisor Kendra Stewart ... Jonathan Resnick from CDER's Office of Business Informatics covers points to consider when preparing your eCTD
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