2023年2月23日
FDA Lifecycle Management Webinar: Regulatory Exclusivity for Novel Drugs and Biologics
Speaker:
Join Mayer Brown FDA Regulatory partner George O’Brien on Thursday, February 23, 2023 at 1:00 p.m. – 2:00 p.m. EST, for the first installment of our webinar series FDA Lifecycle Management. This series will cover legal and regulatory topics that impact the development, marketing and commercialization of pharmaceutical and biotech products, beginning with four sessions on regulatory exclusivity.
In our first webinar, we will provide an overview of 5-Year New Chemical Entity Exclusivity and 12-Year Reference Product Exclusivity, the key exclusivity periods for innovator drug and biological products, respectively. First, George will review the statutory and regulatory framework and its applicability to different categories of drug and biological products. Then he’ll go over recent controversies, their impact on novel product classes, and important strategies for sponsors to ensure the maximum exclusivity award.
In our first webinar, we will provide an overview of 5-Year New Chemical Entity Exclusivity and 12-Year Reference Product Exclusivity, the key exclusivity periods for innovator drug and biological products, respectively. First, George will review the statutory and regulatory framework and its applicability to different categories of drug and biological products. Then he’ll go over recent controversies, their impact on novel product classes, and important strategies for sponsors to ensure the maximum exclusivity award.
