• 21st Century Cures Act & Real World Evidence: Device Policy as Foundation
  • March 8, 2017
  • Law Firm: Mintz Levin Cohn Ferris Glovsky Popeo P.C. - Boston Office
  • The 21st Century Cures Act (the ‘‘Cures Act’’)(Pub. Law 114-255, § 3022), signed by President Obama on December 13, 2016, requires FDA to develop a framework and guidance for evaluating real world evidence (‘‘RWE’’) in the context of drug regulation to (1) support approvals of new indications for previously approved drugs and (2) support or fulfill post-approval study requirements. This directive to apply RWE in the drug sphere is a particularly interesting development since FDA has already issued a draft policy on the use of RWE in the context of medical devices, but has generally been silent about applying RWE to pharmaceutical and biologic regulatory considerations. We will briefly review the RWE policy for devices, FDA’s recent public remarks on RWE, and then provide some predictions on how FDA will implement the RWE policy throughout the different program areas.