FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law

Jacqueline Berman will present for the FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law on a panel titled “Cell and Gene Therapy – Regulatory Frameworks and Exclusivity Concerns”.  Jacqueline and other panelists will discuss FDA efforts to regulate while also spurring innovation, including the scope and availability of orphan drug exclusivity and the regenerative medicine advanced therapy (RMAT) designation. Panelists will also explore the unique development, manufacturing, and post-market monitoring challenges for these complex new technologies.