The FDA’s Approach to DHT is Evolving

The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March. This publication, a PDUFA VII commitment, will “guide activities...

What are the FDA’s Orange, Purple, and Green Books?

Among the many resources made available by the FDA, the Orange, Purple, and Green Books stand out for their names and content. These books address public demand for lower-cost drug products, which prompted laws and regulations requiring lists of alternatives.

The Operational Challenges Inherent to RWD/RWE

In the introduction to my June article, “FDA Guidance for Real-World Data and Evidence,” I said, “This increased activity raises questions about practical approaches to collecting and using RWD in generating RWE and concerns about patient data privacy, ownership, and informed consent.”