Explore the essentials of drug law and regulation and gain a comprehensive understanding of the various 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)
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FDAMA)
  • Food and Drug Administration Amendments Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic Drug User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of drug law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

FDLI thanks Foley Hoag for hosting.

Register

Industry & Firms

$1199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$199
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Curriculum Advisor:  
Jur Strobos, Partner, Baker & McKenzie LLP

Wednesday, June 14

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

David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

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

Michael Stern, Special Counsel, Covington & Burling LLP

1:45–3:20 PM
The New Drug Approval Process: NDA Submission and Review

George O’Brien, Senior Associate, Hogan Lovells US LLP

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

Areta Kupchyk, Partner, Foley Hoag LLP
Marco J. Quina, Partner, Foley Hoag LLP

5:00–6:00 PM
Networking Reception
hosted by Foley Hoag

Thursday, June 15

8:00–8:30 AM
Continental Breakfast

8:30–9:45 AM
Biologics and Biosimilars

Deborah M. Shelton, Partner, McCarter & English LLP

9:45–10:30 AM

Amanda Klingler, Partner, King & Spalding LLP

Post-Approval Issues

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

10:45–11:30 AM
Over-the-Counter Drugs

Heidi Gertner, Partner, Hogan Lovells US LLP

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

David S. Weinstock, Senior Counsel, MannKind Corporation

12:45–2:00 PM
Networking Lunch

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

Asha Natarajan, Senior Associate, DLA Piper LLP (US)

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

3:45–5:00 PM
Violations and Enforcement

Frederick (Rick) Ball, Partner, Duane Morris LLP
Carolyn Alenci, Associate, Duane Morris LLP

5:00 PM
Adjournment

Speaker Biographies

Speaker biographies will be posted as they become available.

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.

Location and Overnight Accommodations

Course Location

Foley Hoag
Seaport West
155 Seaport Boulevard
Boston, MA 02210
Driving, Parking, and Public Transportation

Overnight Accommodations

The following hotels are within walking distance of the meeting location:

Renaissance Boston Waterfront, 606 Congress Street
Seaport Hotel & World Trade Center, 1 Seaport Lane
Intercontinental Boston, 510 Atlantic Avenue
Boston Harbor Hotel, 70 Rowes Warf

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