Category Archives: Press

Why Patient Experience Data Provisions Face Elimination

Jamie Kendall & Alexandra SchulzWhy Patient Experience Data Provisions Face Elimination, Law360, New York (March 22, 2017, 5:05 PM EDT) -- Jamie KendallAlexandra 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…
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What First Amendment? FDA Remains Unfazed By Off-Label Communication Issues

Jamie Kendall & Alexandra Schulz, What First Amendment? FDA Remains Unfazed By Off-Label Communication Issues, Pharm Exec.Com (Mar. 7, 2017), Perhaps it was wishful thinking. Did the industry believe that the FDA would wave its wand and provide clarity on the topic of manufacturer communications regarding unapproved uses of approved or cleared medical products? Apparently,…
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