FDA Questions LabCorp On Its Ovarian Cancer Test Service
This article was originally published in The Pink Sheet Daily
FDA letter could portend agency plans to begin regulating certain lab-developed tests.
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The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.
On the latest Medtech Insight podcast, David Filmore and Ferdous Al-Faruque discuss the unexpected news that Scott Gottlieb is leaving US FDA next month. What has been his legacy for medtech, and who will replace him?
The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.