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 electronically the day of the course:

Who Should Attend

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

Register

Industry & Firms

$1299
  • +$400 for non-members

Non-Profit

$899
  • +$200 for non-members

Government

$899
  • +$200 for non-members

Academic

$899
  • +$200 for non-members

Student

$99
  • full-time students only

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

Agenda

Curriculum Advisor:

Rebecca Dandeker, Partner, Morgan, Lewis & Bockius LLP

 

Tuesday, April 20

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

12:05–1:10 PM
Overview of Drug Law and Regulation
Joseph E. McGuinness, Independent Consultant, EAS Consulting Group

1:10–1:20 PM
Break

1:20–2:35 PM
The New Drug Approval Process: Basic Concepts
Bert Lao, Senior Associate, Hogan Lovells US LLP

2:35–2:45 PM
Break

2:45–4:00 PM
The New Drug Approval Process: New Drug Research and Development
Marian J. Lee, Partner, Gibson Dunn & Crutcher LLP

4:00–4:15 PM
Break

4:15–5:00 PM
FDA’s COVID-19 Activities
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP

 

Wednesday, April 21

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
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP

1:15–1:25 PM
Break

1:25–2:40 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

2:40–2:50 PM
Break

2:50–3:50 PM
Post-Approval Issues
Michelle R. Ryder, Principal Consultant, Lachman Consultant Services, Inc.

3:50–4:00 PM
Break

4:00–5:00 PM
Biologics and Biosimilars
Alexander V. Alfano, Associate, Axinn, Veltrop &Harkrider LLP

 

Thursday, April 22

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
John F. Johnson, III, Of Counsel, Shook, Hardy & Bacon LLP
Hillary Nicholas, Associate, Shook, Hardy & Bacon LLP

1:05–1:15 PM
Break

1:15–2:15 PM
Regulation of Drug Manufacturing
Lindsay P. Holmes, Associate, BakerHostetler

2:15–2:30 PM
Break

2:30–3:30 PM
Regulation of Drug Marketing
Heidi Gertner, Partner, Hogan LovellsUS LLP

3:30–3:45 PM
Break

3:45–5:00 PM
Violations and Enforcement
Tiffany Humphries, Associate, Baker & McKenzie LLP

5:00 PM
Adjournment

 

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.