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 FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and 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 (FDAMA)
  • 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:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher


Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members



Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.


subject to change
All times are in Eastern Daylight Time

Curriculum Advisor:

Rebecca Dandeker, Partner, Morgan, Lewis & Bockius LLP


Preconference Primers

Preconference Primer (Virtual)
Overview of Drug Law and Regulation
Nathan Beaton, Associate, Latham & Watkins LLP
Meryl E. Bartlett, Associate, Latham & Watkins LLP

Preconference Primer (Virtual)
The New Drug Approval Process: Basic Concept
Alexandre Gapihan, Associate, Morgan, Lewis & Bockius LLP

Tuesday, November 9

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM –12:15 PM
The New Drug Approval Process: New Drug Research and Development
Marc Wagner, Associate, BakerHostetler

12:15–1:00 PM
FDA’s COVID-19 Activities
Angela M. Seaton, Partner, Shook, Hardy & Bacon LLP

1:00–1:15 PM

1:15–2:25 PM
The New Drug Approval Process: NDA Submission and Review
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP

2:25–3:35 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius, LLP

3:35–3:50 PM

3:50–5:00 PM
Post-Approval Issues
Frederick A. Stearns, Partner, Kellerand Heckman LLP


Wednesday, November 10

11:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:05 PM
Biologics and Biosimilars
Christopher Gallo, Associate, Axinn, Veltrop & Harkrider LLP

12:05–1:05 PM
Regulation of Over-the-Counter (OTC) Drugs
Deborah L. Livornese, Director, Hyman, Phelps & McNamara, PC

1:05–1:15 PM

1:15–2:15 PM
Regulation of Drug Manufacturing
Peter V. Lindsay, Partner, Paul Hastings

2:15–2:30 PM

2:30–3:30 PM
Regulation of Drug Marketing
Heather Banuelos, Counsel, King & Spalding LLP
Gillian M. Russell, Counsel, King & Spalding LLP

3:30–3:45 PM

3:45–5:00 PM
Violations and Enforcement
Tiffany Humphries, Senior Associate, BakerMcKenzie

5:00 PM

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.