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

I. Origins and Overview of the Food and Drug Administration and the Regulation of Drugs
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker LLP

Watch this session here.

 

 

 

II. The New Drug Approval Process: Basic Concepts
Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP

Watch this session here.

 

Wednesday, November 15

 

11:00 AM 

FDLI Welcome and Announcements
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI

Enter this session: https://fdli.zoom.us/j/82541270411

11:05 AM–12:15 PM 

The New Drug Approval Process: New Drug Research and Development
Justin A. Coen, Partner, Venable LLP

Enter this session: https://fdli.zoom.us/j/82541270411

12:15–12:30 PM 

Break

12:30 PM–1:50 PM 

The New Drug Approval Process: NDA Submission and Review
Elizabeth Mulkey, Associate, Goodwin & Proctor LLP

Enter this session: https://fdli.zoom.us/j/82832913514

 

1:50–2:05 PM

Break

2:05–3:25 PM

The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Joshua Weinger, Partner, Goodwin Procter LLP

Enter this session: https://fdli.zoom.us/j/87060531272?pwd=4p04YDMwYQz2beSEqzk4lk4FqkWqP1.1

3:25–3:40 PM

Break

3:40–5:00 PM

Post-Approval Issues  
Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International

Enter this session: https://fdli.zoom.us/j/82448696078