Tag: <span>viral gene vector</span>

From the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

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…

Read MoreFrom the Editor-in-Chief: I Still Don’t Like Calling Biopharmaceuticals “Drugs”

Biologics Production

biologics bioproduction cber cder cellular therapies drug product FDA monoclonal antibodies odat regenerative tissues subunit vaccines viral gene vector