The regulation of pharmaceutical and biological products often overlaps. This course will provide a comprehensive understanding of the administrative agencies that impact these industries, which FDA center regulates, depending on the product, and how they interact. Learn about the development of drug and biological products, FDA’s review and approval of marketing applications, generic drugs and biosimilars, manufacturing issues, advertising and promotion, and related issues. Case studies, hypotheticals, and ample time for Q&A is provided.

Agenda Highlights

  • Overview of the Food and Drug Administration (FDA) and FDA’s Regulatory Processes
  • FDA review and approval process
  • Regulation of biological/drug development
  • Generic drugs, section 505(b)(2) products, and biosimilars
  • Regulation of biological/drug manufacturing
  • Post-approval safety issues
  • Advertising and promotion requirements
  • Enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • 21stCentury Cures Act
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Prescription Drug User Fee Act (PDUFA)

venue sponsor

Register by June 20 and SAVE!

Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • full-time students only

A Valuable Reference
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th 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.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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 Advisors: 
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP
Michael Stern, Of Counsel, Covington & Burling LLP


Tuesday, July 23

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

8:35–10:25 AM
Origins and Overview of the Food and Drug Administration
Deborah M. Shelton
, Partner, Arent Fox LLP

10:25–10:40 AM
Networking and Refreshment Break

10:40–11:40 AM
FDA’s Regulatory Processes
Eitan N. Bernstein
, Associate, Latham & Watkins LLP

11:40 AM–12:30 PM
New, Emerging and Continually Interesting Issues
Kalah Auchincloss
, Senior Vice President, Greenleaf Health, Inc.

12:30-1:30 PM
Networking Lunch

1:30–3:00 PM
Introduction to FDA Review and Approval of Drugs & Biologics
Teresa (Terry) Stanek Rea, Partner, Crowell & Moring LLP

3:00–3:15 PM
Networking and Refreshment Break

3:15–4:45 PM
Regulation of Biological/Drug Development
Michael Stern, Of Counsel, Covington & Burling LLP

5:00 PM
Reception and Panel Discussion
Hosted by Duane Morris LLP





Wednesday, July 24

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

8:30–10:00 AM
Review and Approval of Abbreviated Applications and Biosimilar Products
Daniel Orr
, Partner, Womble Bond Dickinson (US) LLP

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

10:15–11:00 AM
Post-Approval Issues
David L. Chesney
, Principal and General Manager, DL Chesney Consulting, LLC

11:00 AM–12:00 PM
Networking Lunch

12:00–1:00 PM
Regulation of Manufacturing
Scott Kaplan
, Senior Associate, Hogan Lovells US LLP

1:00–1:15 PM
Networking and Refreshment Break

1:15–2:30 PM
Regulation of Marketing
Carolyn A. Alenci
, Associate, Duane Morris LLP
Frederick R. Ball
, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors

2:30–4:00 PM
Violations, Enforcement, and International Issues
David S. Weinstock
, Sole Practitioner

4:00 PM






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.

Pennsylvania: 12.5 credits
Ohio: 12.5 credits

Location and Overnight Accommodations

Course Location

Duane Morris LLP
100 High Street, Suite 2400
Boston, MA 02110

Parking and Public Transportation

Coming soon.

Overnight Accommodations

A block of rooms has been reserved at the Courtyard Boston Downtown for course attendees. Reservations can be made online. The group rate is $249/night. Reservations must be received by July 1, 2019 to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

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