Home Access Health submits PMA for home-use HIV test system.
This article was originally published in The Gray Sheet
HOME ACCESS HEALTH SUBMITS PMA FOR HOME-USE HIV TEST SYSTEM and asks FDA to expedite review of the premarket approval application, the Chicago-based start-up announced June 1. Home Access Health Corp., formerly known as Anonymous Test Services, says it submitted the PMA following the mid-March completion of multi-center Phase III clinical trials involving more than 1,200 subjects.
You may also be interested in...
Tensions between industry and the European Commission on the issue of health claims for botanical food supplements were aired on the second day of the BAH's High Level Conference on the Future of Medicines, with the EC saying the EU Green Deal is now higher up on its list of priorities for the foreseeable future.
Issues over supply and the use of a skinny label have the potential to take a toll on the market for the fish oil drug icosapent ethyl, one analyst has claimed in the wake of Hikma’s recent generic launch.
The German Bundestag has adopted the Unified Patent Court’s draft ratification bill with the necessary qualified majority.