Articles

Lee Rosebush, Lindsay Holmes, Marc Wagner Author Article about Upcoming Transition of NDAs to BLAs

Articles / February 19, 2020

Partner Lee Rosebush and Associates Lindsay Holmes and Marc Wagner authored an article published Feb. 13, 2020, in the PG Bulletin of the American Health Lawyers Association. The article, “FDA to Convert Some NDAs to BLAs on March 23, 2020,” discusses the Food and Drug Administration’s (FDA) transition of certain New Drug Applications (NDAs) to Biologic License Applications (BLAs) and the removal of those NDAs from the “Orange Book.”

The authors explain why the change is being made, what will occur, and how the transition may affect the industry.

Read the article (registration required).