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 (NDA) process
  • 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

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

Previous Agenda

subject to change

Curriculum Advisor: Michael K. Stern, Of Counsel, Covington & Burling LLP

 

Thursday, April 11

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
Marian J. Lee
, Partner, Gibson Dunn & Crutcher LLP

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

10:15 – 11:15 AM
The New Drug Approval Process: Basic Concepts
George A. O’Brien
, Senior Associate, Hogan Lovells US LLP

11:15 AM – 12:15 PM
Networking Lunch

12:15-1:45 PM
The New Drug Approval Process: New Drug Research and Development
Angela M. Seaton
, Partner, Shook, Hardy & Bacon LLP

1:45 – 3:20 PM
The New Drug Approval Process: NDA Submission and Review
Daniela Drago
, Assistant Professor and Program Director, Regulatory Affairs, George Washington University
Nancy Singer
, Assistant Professor of Clinical Research and Leadership, George Washington University

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

3:35 – 5:00 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Shannon Lentz
, Counsel, Crowell & Moring LLP
Deborah Yellin
, Partner, Crowell & Moring LLP

 

Friday, April 12

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

8:30 – 9:45 AM
Biologics and Biosimilars
Michael K. Stern
, Of Counsel, Covington & Burling LLP

9:45 – 10:45 AM
Post-Approval Issues
Ryan J. Kaat
, Senior Director, Law, PhRMA

10:45 – 11:00 AM
Networking and Refreshment Break

11:00 – 12:00 AM
Regulation of Over-the-Counter (OTC) Drugs
Khelin Aiken
, Counsel, McDermott Will & Emery LLP

12:00 AM – 1:00 PM
Regulation of Drug Manufacturing
James R. Johnson
, Partner, Hogan Lovells US LLP

1:00 – 2:00 PM
Networking Lunch

2:00 – 3:30 PM
Regulation of Drug Marketing
Heather Banuelos
, Counsel, King & Spalding LLP

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

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

5:00 PM
Adjournment