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Panel Discussion (13/28) Generic Drugs Forum 2017
Panel Discussion (19/28) Generic Drugs Forum 2017
Panel Discussion (8/28) Generic Drugs Forum 2017
GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017
Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017
OPQ Communications with Industry (21/28) Generic Drugs Forum 2017
Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017
Generic Drugs Forum (GDF) 2026 - Day 2
Generic Drug Labeling: Recommendations for High-Quality Submissions (4of28) Generic Drugs Forum 2020
OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017
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Last Updated: October 3, 2026
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Michael Kopcha, PhD, RPh, Director, Office of Kathleen Uhl, MD, Director, Office of Presenters respond to audience questions. FDA CDER's Small Business and Industry Assistance (SBIA) educates and provides ... Presenters Lee, Chandra, Ghodasara, Kimble-Vance, Jiang, Kim, Spagnola, and Golson respond to audience questions. Stephanie H. Choi, CDER Office of Rosanne Chandra and Ankit Ghodasara, CDER Office of Dawn Kimble-Vance, CDER Office of This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... Rachel Goehe and Katherine Won from CDER's Office of
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