Articles

Lee Rosebush, Lindsay Holmes, Marc Wagner Article Examines Conversion of Some NDAs to BLAs

Articles / February 13, 2020

Partner Lee Rosebush and Associates Lindsay Holmes and Marc Wagner authored an article published Feb. 13, 2020, by the American Health Law Association. The article, “FDA to Convert Some NDAs to BLAs on March 23, 2020,” discusses the March 23 transition date for the “Deemed to be a License” (Deemed BLA) provision of the Biologics Price Competition and Innovation Act of 2009. The authors note that more stakeholders have become interested in the implications of the move to convert New Drug Applications (NDAs) to Biologic License Applications (BLAs) and remove the NDAs from FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”).

Read the article (registration required).