The U.S. Food and Drug Administration (FDA) is seeking public comment on its new proposed framework on regulations involving software related to prescription drugs.
According to a Regulatory Focus report, FDA Commissioner Scott Gottlieb said during a meeting at the Reagan Udall Foundation that newly-adopted digital solutions are still in their infancy.
“A lot of these technologies haven’t advanced as quickly when it comes to the delivery of medicines because the regulatory pathway has — at times — seemed uncertain. Our aim is to provide that certitude,” Gottlieb said.
The new framework aligns with the agency’s new focus on digital health.