In Brief: Metra Biosystems
This article was originally published in The Gray Sheet
Metra Biosystems: Gains 510(k) clearance for the use of the Pyrilinks-D bone resorption immunoassay to monitor anti-resorptive therapies, including Merck's Fosamax (alendronate), in the treatment and prevention of osteoporosis. The clearance is based upon a randomized, placebo-controlled clinical trial conducted by Merck to demonstrate the efficacy of alendronate in postmenopausal women diagnosed with osteoporosis. First cleared by the FDA in December 1995 for measuring bone resorption, Pyrilinks-D was used in the Merck trial to compare Dpd levels in subjects who received either alendronate and a calcium supplement or a calcium supplement alone...
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.