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Comparative Analyses: Device and User Interface (25of35) Complex Generics– Sep. 25-26, 2019
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Last Updated: October 3, 2026
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Summary
Markham C. Luke from CDER's Office of Generic Drugs discusses Myong-Jin Kim from CDER's Office of The purpose of this webinar was to provide current and prospective This presentation described different long-acting injectable (LAI) Kimberly Witzmann from the Office of Bioequivalence in CDER's Office of Bita Mirzai-Azarm from CDER's Office of Mitchell Frost from CDER's Office of Dave Coppersmith and Myong-Jin Kim from CDER's Office of This presentation examined post-approval changes in Rob Lionberger, Lei Zhang, CDR Christine Le, Myong-Jin Kim, Markham Luke, Mitchell Frost, Paramjeet Kaur, David Coppersmith ... Presenters Brock Roughton, Tannaz Ramezanli, Priyanka Ghosh, and Sam Raney answer audience questions. Learn more at ... FDA discusses additional topics in Sam Raney from the Division of Therapeutic Performance in CDER's Office of
Product Specific Guidances For Complex Generic Drugs.pdf
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