Introduction to U.S. Drug Law and Regulation

Description

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the various 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)
• Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman Act)
• Biologics Control Act
• Food and Drug Administration Safety and Innovation Act (FDASIA)
• Food and Drug Administration Modernization Act (FDAMA)
• Food and Drug Administration Amendments Act (FDAAA)
• Biologics Price Competition and Innovation Act (BPCIA)
• Prescription Drug User Fee Act (PDUFA)
• Generic Drug User Fee Amendments (GDUFA)
• Drug Quality and Security Act (DQSA)
• 21st Century Cures Act

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of drug law and regulation is needed.

Continuing Legal Education

FDLI applies for CLE credits in 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.

Register By May 11 and SAVE!

Click here to view the full agenda.