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Part III: The Impact of Cures on the FDA

Feb
15
2018

Date: February 15, 2018

Time: 1:00PM

Location: Webinar

Topics

  • 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

 

Speakers

Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.
Bethany J. Hills is recognized for her experience and insight on FDA matters. At Mintz, she advises health care providers on pre- and post-market issues. Bethany also helps international and US companies enter and navigate the US health care market.