"Introduction to U.S. Biologics and Biosimilars Law and Regulation," a Food and Drug Law Institute Seminar

Explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A are provided.

Venable attorney Todd Halpern will present "Regulation of Biological Manufacturing" on Day Two of the seminar at 10:00am ET.

Agenda Highlights

• Regulatory processes for biologics
• Review and approval process
• Regulation of biological/drug development
• Biologics License Application (BLA)
• Biosimilar biologic products
• Post-approval safety issues
• Regulation of biological manufacturing
• Advertising and promotion requirements
• Enforcement tools and procedures
• Changes to the statutory framework for regenerative medicine

Statutes Covered

• The 1902 Biologics Act
• Federal Food, Drug & Cosmetic Act (FD&C Act)
• Public Health Service Act of 1944 (PHSA)
• Food and Drug Administration Amendments Act (FDAAA)
• Biologics Price Competition and Innovation Act (BPCIA)
• Food and Drug Administration Safety and Innovation Act (FDASIA)
• Prescription Drug User Fee Act (PDUFA)
• 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

Visit the seminar page for more information and to register for this event.