Year-end review for colon cancer device?:
This article was originally published in Clinica
SpectraScience has said it is confident that the US FDA will review its premarket approval (PMA) application for the Optical Biopsy system for colorectal cancer later this year. The Minneapolis, Minnesota-based company met with the FDA in mid-July to discuss the PMA, which proposes the device's use as an adjunct to colonoscopy to avoid biopsy tissue removal. The next scheduled meeting of the FDA's gastroenterology and urology panel is November 18-19, the company pointed out.
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.
Rushed final rule seeking to impose draconian cuts on drug reimbursement rates in the Medicare Part B program is certain to face legal and political obstacles. But the data included on international price benchmarks will still have an impact.