7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions between generic drug applicants and the two regulatory bodies, with the ultimate goal of improving patient access to harder to develop generic drugs. 

This pilot program is an expansion of FDA and EMA’s existing Parallel Scientific Advice program and focuses on complex generics/“hybrid medicines” (an EMA term for medications that loosely corresponds to complex generics).

Read FDA press release