This article was originally published in The Gray Sheet
Begins European launch of next-generation, fully-automated Isolex 300i positive/negative stem cell selection system. Nexell plans to submit a PMA supplement this year to FDA for the hardware and software modifications to the Isolex 300i positive selection system currently marketed in the U.S. Phase III trials are currently under way
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A recent Department of Health and Human Services proposal to review regulations every 10 years may mean good things for the device industry, said David Hoffmeister, partner, Wilson Sonsini Goodrich & Rosati.
Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.
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.