News

Lee Rosebush a Speaker for FDLI Webinar on Biologics Transition Issues

News / May 1, 2020

Partner Lee Rosebush will be a speaker for a webinar presented by the Food and Drug Law Institute (FDLI) on May 14, 2020. The topic is “The Long-Awaited Biologics Transition Date Has Come: Now What?” March 23, 2020, marked the Biologics Price Competition and Innovation Act transition date, on which nearly 100 drugs previously approved as new drugs under Food, Drug, and Cosmetic Act section 505 transitioned to approved biologics licenses under section 351 of the Public Health Service Act. This webinar will address transition questions, regulatory pathways and potential pricing implications.

More information.