US FDA advisory panels to drop vote on approvability in favour of benefit:risk
This article was originally published in RAJ Devices
The US Food and Drug Administration is to change to the way its medical device advisory committees discuss data and information during public hearings on products under review for premarket approval (PMA). The change will apply from 1 May1,2.
You may also be interested in...
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.