Australia issues IVD declaration of conformity templates
This article was originally published in Clinica
The Australian Therapeutic Goods Administration has published templates under its new in vitro diagnostics framework that manufacturers can use to declare conformity with the relevant essential principles, classification rules and the appropriate conformity assessment procedure.
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.