Day 1

 

Day 2
Resources

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.

 

 

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

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Wednesday, November 9

 

11:00 AM 

FDLI Welcome and Announcements

Enter this session: https://fdli.zoom.us/j/89525686128

11:05 AM–12:15 PM 

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

Enter this session: https://fdli.zoom.us/j/89525686128

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12:15–12:30 PM 

Break

12:30–1:50 PM 

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

Enter this session: https://fdli.zoom.us/j/86273959855

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1:50–2:05 PM

Break

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

Enter this session: https://fdli.zoom.us/j/86103240234

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3:25–3:40 PM

Break

3:40–5:00 PM

Post-Approval Issues
Lee Rosebush, Partner, BakerHostetler

Enter this session: https://fdli.zoom.us/j/88324673543

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