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

Register

Industry & Firms

$1399
  • +$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

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.

Agenda

subject to change

All times listed are in Eastern Time

2022 Curriculum Advisor:
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

 

Preconference Primers

Preconference Primer (Virtual) (60 Minutes)
Overview of Drug Law and Regulation
Alexandre Gapihan, Associate,Morgan, Lewis & Bockius LLP

Preconference Primer (Virtual) (75 Minutes)
The New Drug Approval Process: Basic Concepts
Nathan A. Beaton, Associate, Latham & Watkins LLP

Wednesday, April 27

11:00 AM
FDLI Welcome and Announcements

11:05 AM –12:15 PM
The New Drug Approval Process: New Drug Research and Development
Lee Rosebush, Partner, Baker Hostetler

12:15–12:25 PM
Break

12:25–1:35 PM
The New Drug Approval Process: NDA Submission and Review
Charles G. Raver, Associate, Hyman, Phelps, & McNamara, PC

1:35–1:40 PM
Break

1:40–2:50 PM
 The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

2:50–3:00 PM
Break

3:00–4:10 PM
Post-Approval Issues
David L. Rosen, Partner, Foley & Lardner LLP

4:10–4:20 PM
Break

4:20–5:20 PM
Biologics and Biosimilars
Emily Marden, Counsel, Sidley Austin LLP

 

 

 

 

 

 

 

 

Thursday, April 28

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:05 PM
FDA’s COVID-19 Activities
Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett

12:05–12:15 PM
Break

12:15–1:15 PM
Regulation of Over-the-Counter (OTC) Drugs
Douglas B. Farquhar, Director, Hyman, Phelps & McNamara, PC

1:15–1:25 PM
Break

1:25–2:25 PM
Regulation of Drug Manufacturing
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

2:25–2:35 PM
Break

2:35–3:35 PM
Regulation of Drug Marketing
Alan G. Minsk, Partner, Arnall Golden Gregory LLP

3:35–3:45 PM
Break

3:45–5:00 PM
Violations and Enforcement
Frederick R. Ball, Partner, Duane Morris LLP, FDLI Board of Directors

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.