Skip to main content

Part III: The Impact of Cures on the FDA


Date: February 15, 2018

Time: 8:00AM - 9:00AM

Location: Webinar


  • 21st Century Cures Act Webinar Series

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



Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.