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 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


Industry & Firms

  • +$400 for nonmembers


  • +$200 for nonmembers


  • +$200 for nonmembers


  • +$200 for nonmembers


  • full-time students only
Register Now

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 Advisor:
Lee Rosebush, Partner, BakerHostetler

Tuesday, July 24

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
Karen Corallo
, Of Counsel, Greenberg Traurig LLP

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

10:15–11:15 AM
New Drug Approval Process: Basic Concepts
Benjamin L. England
, Founder and CEO, FDAImports.com, LLC/Benjamin L. England & Associates LLC

11:15 AM–12:15 PM
Networking Lunch

12:15-1:45 PM
New Drug Approval Process: New Drug Research and Development
Michael K. Stern
, Of Counsel, Covington & Burling LLP

1:45–3:20 PM
The New Drug Approval Process
Nathan A. Beaver
, Partner, Foley & Lardner LLP
Kyle Y. Faget, Special Counsel, Foley & Lardner 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
Vinita Kailasanath
, Associate, Arnold & Porter LLP
Abeba Habtemariam, Associate, Arnold & Porter LLP





Wednesday, July 25

8:00–8:30 AM
Continental Breakfast

8:30–9:30 AM
Biologics and Biosimilars
Barbara A. Binzak Blumenfeld
, Partner, Buchanan Ingersoll & Rooney PC

9:30–10:30 AM
Post-Approval Issues
Lee Rosebush
, Partner, BakerHostetler

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

10:45–11:30 AM
Regulation of Over-the-Counter (OTC) Drugs
Scott L. Cunningham
, Covington & Burling LLP

11:30 AM–12:30 PM
Regulation of Drug Manufacturing
Michael A. Swit
, Partner, Law Offices of Michael A. Swit

12:30–1:30 PM
Networking Lunch

1:30–2:30 PM
Regulation of Drug Marketing
Morgan A. Rettig
, Associate, Latham & Watkins LLP
Amy E. Speros, Associate, Latham & Watkins LLP

2:30–2:45 PM
Networking and Refreshment Break

2:45–3:45 PM
Violations and Enforcement
Mark Mansour
, Partner, Foley Hoag

3:45 PM

4:00 PM
A Presentation and Panel Discussion: FDA’s Digital Health Innovation Action Plan – Key Updates
Being held nearby. A separate registration is required.


Continuing Legal Education

FDLI applies for CLE credits in California, 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.

12.5 credits approved for Pennsylvania
12.5 credits approved for Virginia
11.75 credits approved for Ohio

Course Location

California Life Sciences Association
701 Gateway Blvd, Suite 440
South San Francisco, CA 94080


A block of rooms has been reserved for course attendees at the AC Hotel San Francisco Airport/Oyster Point Waterfront. The group rate is $279/night plus tax. Reservations can be made online or by calling 1-888-236-2427. Reservations must be received by June 29, 2018 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.