This article was originally published in The Gray Sheet
FDA "approvable" letter says that the firm's premarket approval application for the Isolex 300 stem cell selection system and the PMA supplement for the fully automated Isolex 300i can be approved "subject to the submission of additional information needed primarily to finalize labeling and the inspection of manufacturing facilities," the VIMRx Pharmaceuticals subsidiary says Jan. 8. Upon approval, Isolex will be distributed by Nexell minority owner Baxter, which has been distributing CellPro's Ceprate stem cell concentration system since the firm declared bankruptcy in late September ("The Gray Sheet" Oct. 5, 1998, p. 13)
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.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.