FDA Guidance News In Brief
This article was originally published in The Gray Sheet
Executive Summary
HIV drug resistance testing: Aug. 8 guidance describes two pathways - one involving only analytical testing and the other combining analytical and clinical testing - for 510(k) clearance of assays that detect HIV mutations associated with drug resistance. The Class II special controls guidance accompanies a rule reclassifying HIV drug resistance genotype assays from Class III to II...
You may also be interested in...
Regulatory News In Brief
FDA released a final rule on protections for children in clinical trials and a final guidance on financial disclosures by investigators. More regulatory news.
Stem Cell Therapy Needs More Than Just The Cells: Device Firms See Opening
The advent of stem cell therapy to future medicine will be facilitated by medical devices that actually process and store the cells. At least two firms already see near-term opportunities to pioneer the technology
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.