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Electronic Submissions (7of27) Generic Drugs Forum 2018
Electronic Submissions- FDA Generic Drugs Forum 2018
Electronic Submissions- FDA Generic Drugs Forum 2018
Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15of27) Generic Drugs Forum 2018
GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018
Good ANDA Submission and Assessment Practices and Software Support- FDA Generic Drug Forum 2018
ANDA Performance/Operations Update (3of27) Generic Drugs Forum April 2018
Keynote Address by Dr. Uhl (1of27) Generic Drugs Forum 2018
Determining Whether to Submit an ANDA or a 505(b)(2) Application (12of27) Generic Drugs Forum 2018
Good ANDA Submission and Assessment Practices and Software Support - FDA Generic Drug Forum 2018
Pre-ANDA Interactions with the FDA (6of16) Generic Drugs Forum 2020
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Last Updated: October 3, 2026
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Summary
Associate Director for Regulatory Affairs in CDER OGD's Office of Research and Standards (ORS) Kris André discusses Lisa Bercu and Sarah Kurtz from the Office of CDER's Jonathan Resnick covers points to consider when preparing an eCTD Kris André, Associate Director for Regulatory Affairs in CDER OGD's Office of Research and Standards (ORS), and Katherine ... Edward “Ted” Sherwood, director of CDER's Office of Elizabeth Giaquinto Friedman's presentation is designed to familiarize potential Kris Andre from CDER's Office of
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