Michael Blume will present at FDLI's seminar, Introduction to U.S. Drug Law and Regulation, on April 13, 2018, on the topic of violations and enforcements. Attendees will explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. They will also learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Venable’s Washington, DC office will host the two-day program.
- 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
Michael Blume, Partner, Venable LLP
Please visit FDLI's page for more information and to register.