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:
- A binder of speaker handouts and related reference materials.
- Access to an electronic copy of the FDCA Statutory Supplement, 2018.
Who Should Attend
- New legal and regulatory professionals
- Seasoned practitioners new to the topic or wanting a refresher
Register
Industry & Firms
- +$400 for non-members
Non-Profit
- +$200 for non-members
Government
- +$200 for non-members
Academic
- +$200 for non-members
Student
- 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.
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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.