Day 1

 

Day 2
Resources

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

Prerecorded 

Overview of Drug Law and Regulation
Alexandre Gapihan, Associate,Morgan, Lewis & Bockius LLP

Watch this session here.

The New Drug Approval Process: Basic Concepts
Nathan A. Beaton, Associate, Latham & Watkins LLP

Watch this session here.

Wednesday, April 27

11:00 AM 

FDLI Welcome and Announcements

Enter this session: https://fdli.zoom.us/j/82411342305

11:05 AM – 12:15 PM 

The New Drug Approval Process: New Drug Research and Development
Lee Rosebush, Partner, Baker Hostetler

Enter this session: https://fdli.zoom.us/j/82411342305

12:15 – 12:25 PM 

Break

12:25 – 1:35 PM 

The New Drug Approval Process: NDA Submission and Review
Charles G. Raver, Associate, Hyman, Phelps, & McNamara, PC

Enter this session: https://fdli.zoom.us/j/88278133348

1:35 – 1:40 PM

Break

1:40 – 2:50 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/87964795613

2:50 – 3:00 PM

Break

3:00 – 4:10 PM

Post-Approval Issues
David L. Rosen, Partner, Foley & Lardner LLP

Enter this session: https://fdli.zoom.us/j/83397018482

4:10 – 4:20 PM

Break

4:20 – 5:20 PM

Biologics and Biosimilars
Emily Marden, Counsel, Sidley Austin LLP

Enter this session: https://fdli.zoom.us/j/86069125929

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