By Louis Garguilo, Chief Editor, Outsourced Pharma
A reader pulled me down an Alice-In-Wonderland rabbit hole. I’m glad she did, though. If you read the headline above and thought, “What exactly is a 503B?” you’ll be glad, too.
But we won’t make this a disorienting adventure. Instead, we’ll learn what this group of “outsourcers” does, its (government-defined) parameters of operations, and how it might connect to your own drug development and manufacturing activities — more precisely, your CDMOs.