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 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

$1299
  • +$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
  • full-time students only

COVID-19 Update

In light of travel restrictions due to COVID-19 and out of concern for the safety of our community, FDLI will solely be holding its upcoming programs as virtual events. The registration process remains unchanged. FDLI will contact all registrants with more information regarding virtual access closer to each program’s respective event date.

Register Now

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Add This Must-Have Reference to Your Registration

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.

Agenda

subject to change

Curriculum Advisor:

Deborah M. Shelton, Partner, Arent Fox LLP

 

Wednesday, April 15

8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–9:35 AM
Overview of Drug Law and Regulation
Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

9:35–9:50 AM
Break

9:50–11:15 AM
The New Drug Approval Process: Basic Concepts
Rebecca Dandeker, Partner, Morgan, Lewis & Bockius LLP

11:15–12:15 PM
Lunch Break

12:15-1:45 PM
The New Drug Approval Process: New Drug Research and Development
Marian J. Lee, Partner, Gibson, Dunn & Crutcher LLP

1:45–3:20 PM
The New Drug Approval Process: NDA Submission and Review
Kyle Y. Faget, Of Counsel, Foley & Lardner LLP

3:20–3:35 PM
Break

3:35–5:00 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Radhika Rajagopalan, Independent Consultant, EAS Consulting Group

 

Thursday, April 16

8:30–9:45 AM
Biologics and Biosimilars
Suchira Ghosh, Of Counsel, Hyman, Phelps & McNamara, PC

9:45–10:45 AM
Post-Approval Issues
Mantej (Nimi) Chhina, Senior Director and Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc

10:45–11:00 AM
Break

11:00 AM–12:00 PM
Regulation of Over-the-Counter (OTC) Drugs
Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP
Genevieve M. Razick, Associate, Arnall Golden GregoryLLP

12:00–1:00 PM
Regulation of Drug Manufacturing
Cathy L. Burgess, Partner, Alston & Bird LLP

1:00–2:00 PM
Lunch Break

2:00–3:30 PM
Regulation of Drug Marketing
Jur Strobos, Partner, Potomac Law Group

3:30–3:45 PM
Break

3:45–5:00 PM
Violations and Enforcement
Daniel G. Jarcho, Partner, Alston & Bird LLP

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.