Overview on Drug Substance Review Anda 2228 Generic Drugs Forum 2017
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Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017
GDUFA II (9/28) Generic Drugs Forum 2017
Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017
Panel Discussion (8/28) Generic Drugs Forum 2017
ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017
eCTD (7/28) Generic Drugs Forum 2017
Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017
Good ANDA Submission and Assessment Practices and Software Support (5of27) Generic Drugs Forum 2018
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017
Panel Discussion (13/28) Generic Drugs Forum 2017
Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017
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Last Updated: October 3, 2026
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Summary
Rosanne Chandra and Ankit Ghodasara, CDER Office of Martha Nguyen and Maarika Kimbrell, CDER Office of Kathleen Uhl, MD, Director, Office of Amy Bertha, CDER Office of Executive Programs, covers Presenters respond to audience questions. FDA CDER's Small Business and Industry Assistance (SBIA) educates and provides ... Edward “Ted” Sherwood, CDER Office of Jonathan Resnick, CDER, covers eCTD deadlines, the differences between 1st, 2nd, and 3rd acknowledgement notices, and ... Michael Kopcha, PhD, RPh, Director, Office of Lisa Bercu and Sarah Kurtz from the Office of Dawn Kimble-Vance, CDER Office of
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