Day 1


Please find the session links next to their corresponding agenda item.

Overview of Drug Law and Regulation
Jur Strobos, Partner, Potomac Law Group

Watch this session here.



The New Drug Approval Process: Basic Concepts
Jennifer A. Davidson, Partner, Kleinfeld, Kaplan & Becker, LLP

Watch this session here.




Wednesday, November 9


11:00 AM 

FDLI Welcome and Announcements

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11:05 AM–12:15 PM 

The New Drug Approval Process: New Drug Research and Development
Marc Wagner, Associate, BakerHostetler

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12:15–12:30 PM 


12:30–1:50 PM 

The New Drug Approval Process: NDA Submission and Review
Lauren Farruggia, Associate, Goodwin Procter LLP

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1:50–2:05 PM


2:05–3:25 PM

The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

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3:25–3:40 PM


3:40–5:00 PM

Post-Approval Issues
Lee Rosebush, Partner, BakerHostetler

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