The draft concept paper, released on April 7, 2005, 3 describes the Agency's preliminary thoughts on how to prospectively co-develop a drug or biological therapy (drugs) and a device (test) in a ...

Imaging biomarkers have an increasingly important function in drug discovery and development as a key bridge between the laboratory and the clinic. Indeed, imaging was highlighted in the FDA's ...

Have you ever had an idea and wondered, "Will this work?" That's where "Proof of Concept" comes in. Think of it as a small test or experiment for your idea. Before diving in fully, you try out a basic ...