Introduction to Drug Law and Regulation

November 18–19, 2025 | Virtual Course

Preliminary Agenda

Agenda Subject to Change
All Times Listed in Eastern Time

Preconference Primers

Preconference Primer (Virtual) (60 Minutes)
Overview of Drug Law and Regulation

Preconference Primer (Virtual) (75 Minutes)
The New Drug Approval Process: Basic Concepts

Tuesday, November 18

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:15 PM
The New Drug Approval Process: New Drug Research and Development

12:15 PM–12:30 PM
Break

12:30–1:50 PM
The New Drug Approval Process: NDA Submission and Review

1:50–2:05 PM
Break

2:05–3:25 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

3:25–3:40 PM
Break

3:40–5:00 PM
Post-Approval Issues  

Wednesday, November 19

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:05 PM
Biologics and Biosimilars 

12:05–12:20 PM
Break

12:20–1:20 PM
Regulation of Over-the-Counter (OTC) Drugs

1:20–1:35 PM
Break

1:35–2:35 PM
Regulation of Drug Manufacturing

2:35–2:50 PM
Break

2:50–3:50 PM
Regulation of Drug Marketing

3:50–4:00 PM
Break                                        

4:00–5:00 PM
Violations and Enforcement

5:00 PM
Adjournment