Day: September 24, 2020

This week FDA announced a new Digital Health Center of Excellence within CDRH with an explicit mandate to provide advice and support to developers of digital health products. The Center would consolidate FDA resources to create policies and support infrastructure for review of software and digital health products, address cybersecurity issues, evaluate tools based on … Read more

FDA enforcement officials would have to reach a higher standard of evidence for accusing a manufacturer for off-label promotion. This week FDA released a new rule describing a wholistic approach to assess the intent of a manufacturer to promote new uses of a previous-approved product thereby creating flexibility in enforcement of marketing practices unlike any … Read more