Part III: The Impact of Cures on the FDA

The Cures Act was a vehicle for multiple diverse changes to FDA’s oversight of medical products.  From medical device innovation pathways; the acceleration of new indications for drugs and biologics by leveraging “real world evidence”; and clarifying the process for combination product jurisdictional determinations, the Act included something for everyone who has to interact with the Agency.  Part III of our series will examine the following significant FDA-related provisions of this bipartisan legislation with a deep dive into the practical implications and implementation processes:

• Regenerative medicine
• Medical software/digital health
• FDA restructuring/structural improvements
• Health care economic info and off-label communications
• Data source changes - patient experience, RWE and summary data