Canada Proposes 30-Day Limit For Hospitals To Report Safety Incidents With Devices
Health Canada wants to make it mandatory for certain hospitals to report safety incidents relating to drugs and medical devices, and it is inviting feedback on the minimum information that should be submitted in relation to such incidents and the reporting timelines.
You may also be interested in...
The Canadian government has made it mandatory for hospitals to report medical device incidents and serious adverse reactions in their control irrespective of where these incidents originate.
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.