This article was originally published in The Gray Sheet
Firm is seeking an exclusive marketing and distribution partner for its DRx quantitative hCG patient monitor, for which FDA market go-ahead was announced Oct. 6. The single-use device measures levels of human chorionic gonadotropin (hCG) hormone in whole blood and is designed for use as an aid in monitoring pregnancy status. The test can be performed in a physician's office and provides results in less than ten minutes, according to the company
You may also be interested in...
Beiersdorf and former owner Bayer are on the verge of settling a proposed class action in California’s Northern District challenging “mineral-based” claims on Coppertone sunscreens that also contain chemical UV filters. However, the parties will have to try again with their proposed terms.
The MHRA is in listening mode as it gathers feedback to shape the UKCA marking for medical devices. See what Phil Brown, regulatory director of the Association of British HealthTech Industries, said about it here.
Following a memorable cancer drug advisory panel meeting where FDA explained how accelerated approvals may be more at risk due to changing standard of care, ChemoCentryx’s ANCA-vasculitis treatment runs into trouble because of another drug’s changing indication during their Phase III study.