CardioGenesis concurs with FDA on heart laser trial
This article was originally published in Clinica
CardioGenesis says that an agreement has been reached with the US FDA as to what steps are needed for the initiation of yet another clinical trial of its controversial percutaneous laser treatment for angina.
You may also be interested in...
The FDA’s OPQ touts approval of sixth and seventh continuously manufactured drugs and quicker delivery of inspection results in latest annual report.
No device-related warning letters were released by the US FDA the week of 19 February.
Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.