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