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…
Tag: <span>cder</span>
“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…