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)
  • 21st Century Cures Act
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Prescription Drug User Fee Act (PDUFA)

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


Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • full-time students only

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A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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.


Curriculum Advisors

Patrick C. Gallagher, Partner, Duane Morris LLP

Deborah M. Shelton, Partner, Arent Fox LLP


Tuesday, August 11

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

 12:05–1:05 PM
Origins and Overview of the Food and Drug Administration
Christina M. Markus
, Partner,King & Spalding LLP

1:05–1:15 PM

1:15–2:15 PM
FDA’s Regulatory Processes
Nathan Beaton
, Associate, Latham & Watkins LLP
Barrett Tenbarge, Associate, Latham & Watkins LLP

2:15–2:30 PM

2:30–4:00 PM
Introduction to FDA Review and Approval of Drugs & Biologics
Sonali P. Gunawardhana
, Of Counsel, Shook, Hardy & Bacon LLP
John F. Johnson, III
, Of Counsel, Shook, Hardy & Bacon LLP





Wednesday, August 12

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:35 PM
Regulation of Biological/Drug Development
Lora Spencer
, Associate, Reed Smith LLP

1:35–1:45 PM

1:45–2:30 PM
Emergency Use Authorizations (EUAs) Amid COVID-19
Deborah L. Livornese
, Director, Hyman, Phelps & McNamara, PC

2:30–2:45 PM

2:45–4:15 PM
Review and Approval of Abbreviated Applications and Biosimilar Products
Suchira Ghosh,
Of Counsel, Hyman, Phelps & McNamara, PC



Thursday, August 13

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Post-Approval Issues
Heidi Stuttz
, Independent Consultant, EAS Consulting Group

1:05–1:15 PM

1:15–2:15 PM
Regulation of Manufacturing
Scott Kaplan
, Counsel, Hogan Lovells US LLP
Christopher Fanelli, Senior Associate, Hogan Lovells US LLP

2:15–2:30 PM

2:30–3:30 PM
Regulation of Marketing
Deborah L. Livornese
, Director, Hyman, Phelps & McNamara, PC

3:30–5:00 PM
Violations, Enforcement, and International Issues
Mark C. Levy
, Member, Eckert Seamans Cherin & Mellott, LLC

5:00 PM




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.