The US FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug.

U.S. Senator Mark Kelly (D-AZ) winds his watch as he departs the Senate floor after an evening vote at the U.S. Capitol in Washington, D.C., U.S., January 12, 2026. REUTERS/Jonathan Ernst/File Photo A ...