FDA may complete review of controversial heart laser next month
This article was originally published in Clinica
After cancelling a hearing before a US FDA dispute panel regarding its marketing application for its controversial heart laser treatment in July this year, CardioGenesis believes the agency may complete its "interactive" review of the application by the middle of next month.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.