Why Patient Experience Data Provisions Face Elimination

Law360, New York (March 22, 2017, 5:05 PM EDT) -- Jamie Kendall

Alexandra Schulz Leading up to and following the passage of the 21st Century Cures Act[1], much was made of the so-called "patient experience data" provisions and their impact on the U.S. Food and Drug Administration's regulatory decisions. Patient advocacy groups rallied for the inclusion to champion the patient perspective and bring attention to their diseases and the FDA followed suit by supporting the enactment of the Cures Act for the same reasons.[2] Opponents vocally criticized the inclusion of patient experience data as yet another tool to cloud FDA's judgment on drug efficacy and safety, and pointed to the approval...

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