By Keith L. Carson
Volume 16, Issue 1 (Spring 2017)
When I go to a therapeutic protein meeting, it’s very hard for me to hear these products referred to as “drugs.” But since they are being regulated by CDER, it’s a little easier to swallow. However, calling viral gene vectors and cellular therapies “drugs” is a bridge too far. My advice to my good friends at CBER is to keep calling their products “biologics,” or they may lose all of their regulatory responsibilities to CDER…
Citation: Carson KL. From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs.” BioProcess J, 2017; 16(1): 3. https://doi.org/10.12665/J161.Carson
Posted online July 28, 2026