FDLI's Introduction to Drug Law and Regulation – November 2021

This program will explore the essentials of drug law and regulation and attendees will gain a comprehensive understanding of the FDA Centers that oversee new drug and biologic approvals. 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 a Q&A will be provided.

Rebecca will speak on the topic “The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues.” Rebecca also serves as Curriculum Advisor for this two-day program.

Alex will speak on the topic “The New Drug Approval Process: Basic Concepts.”