FDA's Digital Health Technologies Framework Addresses Important Challenges

In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” This framework goes part of the way in satisfying the FDA’s commitments promised under the PDUFA VII and addresses a few important challenges associated with the use of DHTs in drug, device, and biologics product development. Here is what you need to know.

FDA’s Digital Health Technologies Framework Addresses Important Challenges (meddeviceonline.com)