FDA considers its position on vexed topic of device reuse
This article was originally published in Clinica
The US FDA has finally agreed to take a stand on the reuse of single-use devices, a controversial issue it has been ducking for years, even though parties on all sides have been urging it to act. Last week the agency announced that it would offer a "straw man" proposal no later than October outlining what the agency "thinks it will do".
You may also be interested in...
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.