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 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 onsite:

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


  • full-time students only

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A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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

Curriculum Advisor: Deborah M. Shelton, Partner, Arent Fox LLP 

Monday, November 9

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:35 PM
Overview of Drug Law and Regulation
Nathan A. Beaton
, Associate, Latham & Watkins LLP

1:35–1:45 PM

1:45–3:00 PM
The New Drug Approval Process: Basic Concepts
Rebecca Dandeker
, Partner, Morgan, Lewis & Bockius LLP

3:00–3:15 PM

3:15-4:30 PM
The New Drug Approval Process: New Drug Research and Development
Lee Rosebush
, Partner, BakerHostetler




Tuesday, November 10

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:15 PM
The New Drug Approval Process: NDA Submission and Review
Priya Jambhekar
, Independent Consultant, EAS Consulting Group

1:15–1:25 PM

1:25–2:40 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Komal Karnik Nigam
, Senior Associate, Hogan Lovells US LLP

2:40–2:50 PM

2:50–3:50 PM
Post-Approval Issues
Mantej (Nimi) Chhina, Senior Director and Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc.

3:50–4:00 PM

4:00–5:00 PM
Biologics and Biosimilars
Christopher M. Mikson
, Partner, DLA Piper LLP (US)



Thursday, November 12

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05 PM–1:05 PM
Regulation of Over-the-Counter (OTC) Drugs

Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP
Genevieve M. Razick, Associate, Arnall Golden Gregory LLP

1:05–1:15 PM

1:15–2:15 PM
Regulation of Drug Manufacturing
Howard R. Sklamberg
, Partner, Arnold & Porter LLP

2:15–2:30 PM

2:30–3:30 PM
Regulation of Drug Marketing
Jur Strobos, Partner, Potomac Law Group

3:30–3:45 PM

3:45–5:00 PM
Violations and Enforcement
Peter J. Leininger
, Partner, King & Spalding LLP

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.