CDRH postmarket reengineering team
This article was originally published in The Gray Sheet
Thirteen-member group is conducting weekly meetings to collect feedback on postmarket surveillance and discuss potential initiatives. Brian Harvey, CDRH Office of Device Evaluation, co-heads the team with Tom Gross from the Office of Surveillance and Biometrics. After presenting project ideas to outgoing center Director Bruce Burlington Feb. 19, the team will split into subgroups to design pilot programs in areas such as MDR reporting, device tracking, surveillance and Sentinel reporting. The pilots should be in place by early summer
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.