Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and the new regulatory pathway for biosimilars
  • Post-approval drug safety issues
  • Advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Kefauver-Harris Amendments
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FADAMA)
  • Food and Drug Administration Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

Venue Sponsor 

for hosting.

Register by March 8 and SAVE

Industry & Firms

  • +$400 for nonmembers
  • +$100 after 3/8/18


  • +$200 for nonmembers
  • +$100 after 3/8/18


  • +$200 for nonmembers
  • +$100 after 3/8/18


  • +$200 for nonmembers
  • +$100 after 3/8/18


  • +100 for nonmembers
  • +$100 after 3/8/17
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Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2018 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. The book will be shipped directly to you.


subject to change

Curriculum Advisor:
Lee Rosebush, Partner, BakerHostetler

Thursday, April 12

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–10:00 AM
Overview of Drug Law and Regulation

10:00–10:15 AM
Networking and Refreshment Break

10:15–11:15 AM
New Drug Approval Process: Basic Concepts

11:15 AM–12:15 PM
Networking Lunch

12:15-1:45 PM
New Drug Approval Process: New Drug Research and Development

1:45–3:20 PM
The New Drug Approval Process

3:20–3:35 PM
Networking and Refreshment Break

3:35–5:00 PM
Abbreviated NDA, 505(b)(2) Applications, and Patent and Exclusivity Issues 

Friday, April 13

8:00–8:30 AM
Continental Breakfast

8:30–9:45 AM
Biologics and Biosimilars

9:45–10:30 AM
Post-Approval Issues

10:30–10:45 AM
Networking and Refreshment Break

10:45–11:30 AM
Regulation of Over-the-Counter (OTC) Drugs

11:30 AM–12:45 PM
Regulation of Drug Manufacturing

12:45–2:00 PM
Networking Lunch

2:00–3:30 PM
Regulation of Drug Marketing

3:30–3:45 PM
Networking and Refreshment Break

3:45–5:00 PM
Violations and Enforcement

5:00 PM

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Approved 13.0 credits Virginia

Location and Overnight Accommodations


Venable LLP
600 Massachusetts Ave. NW
Washington, DC 20001

The course location is within walking distance from the Gallery Place (green, yellow and red lines) and Mt. Vernon Square (green and yellow lines) Metro stations.  Parking is available for $20 per day in the adjacent garage through the entrance on Massachusetts Avenue NW. 

Overnight Accommodations

A block of rooms has been reserved at the Fairfield Inn and Suites, located in walking distance of the course location.   Reservations can be made online. The group rate is $253/night. Reservations must be received by March 8, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.