Introduction to Drug Law and Regulation
April 22–23, 2025 | In-Person Course
Preliminary Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Tuesday, April 22
8:00-8:30 AM
Registration and Breakfast
8:30-8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
8:35-9:35 AM
Overview of Drug Law and Regulation
9:35-9:50 AM
Networking Break
9:50-11:05 AM
The New Drug Approval Process: Basic Concepts
11:05-11:20 AM
Networking Break
11:20 AM-12:35 PM
The New Drug Approval Process: New Drug Research and Development
12:35-1:35 PM
Networking Break
1:35-2:50 PM
The New Drug Approval Process: NDA Submission and Review
2:50-3:05 PM
Networking Break
3:05–4:20 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Wednesday, April 23
8:00-8:30 AM
Registration and Breakfast
8:30-8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
8:35–9:50 AM
Post-Approval Issues
9:50–10:05 AM
Networking Break
10:05–11:05 AM
Biologics and Biosimilars
11:05–11:20 AM
Networking Break
11:20 AM–12:20 PM
Regulation of Over-the-Counter (OTC) Drugs
12:20–1:20 PM
Networking Lunch
1:20–2:30 PM
Regulation of Drug Manufacturing
2:30–2:45 PM
Networking Break
2:45–3:45 PM
Regulation of Drug Marketing
3:45–4:00 PM
Networking Break
4:00–5:00 PM
Violations and Enforcement
5:00 PM
Adjournment