In Case You Missed It: Top 10 "Gray Sheet" Stories In September
This article was originally published in The Gray Sheet
Executive Summary
Our most popular stories last month focused on tips from FDA experts on facility inspections, various legal trends, and Robert Califf's nomination to head FDA, among other topics.
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Another Medtronic Preemption Case Appealed to High Court
A case questioning whether patients can sue device makers if a PMA-approved device is marketed for off-label uses may be headed to the Supreme Court, following a recent petition for a writ of certiorari.
Science Evolution At FDA ‘Transformative,’ Advisors Say
An FDA Science Board subcommittee report finds industry and researcher perceptions of FDA's science readiness has improved over the past eight years. But the agency still faces major challenges tied to the current speed of scientific and technical progress.
Off-label, Failure-to-Warn Preemption Cases May Head to Supreme Court
While federal preemption of state suits for PMA-approved has been strongly validated by the Supreme Court, two types of plaintiffs' claims in particular offer the potential for the PMA preemption device to be considered once again by the high court, according to Mayer Brown partner Andrew Tauber.