Amendments made by Section 504 of the 2017 FDA Reauthorization Act (FDARA) to section 505B of the Food, Drug, and Cosmetic Act required, for original applications submitted on or after August 18, 2020, pediatric investigations of certain targeted cancer drugs with new active ingredients, based on molecular mechanism of action rather than clinical indication. The Committee will discuss perspectives relating to implementation of this legislation and its impact on pediatric cancer drug development to date.
