RAPS July 25, 2019
Novartis CEO Vas Narasimhan told attendees of PhRMA’s Innovation Day on Thursday that as biopharmaceutical companies embrace digital technologies to speed the discovery and development of new medicines, regulators will have to adapt more quickly.
“FDA has been, more than any other regulator in the world, interested in working with these technologies,” Narasimhan said. But he also opined that when the “rubber hits the road” and companies begin filing applications with these technologies, “will we hit brick walls? I think yes.”
For its part, FDA has been working with digital health and technology companies on a precertification program for software-based medical devices. And the agency also has released draft guidance on clinical decision support software, but industry has pushed back...
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