The evolving role of real-world evidence in medical device approvals in the United States

Affiliations

• ¹ HEOR Department, Neurocrine Biosciences, Inc., San Diego, CA, USA.
• ² Department of Pharmacy Administration, University of Mississippi, University, MS, USA.
• ³ Department of Pharmaceutical Health Outcomes and Policy, University of Houston, Houston, TX, USA.
• ⁴ HEOR Department, UCB, Atlanta, GA, USA.
• ⁵ Regulatory Affairs Department, Hycor Biomedical LLC, Garden Grove, CA, USA.
• ⁶ Department of Regulatory and Quality Sciences, University of Southern California, Los Angeles, CA, USA.