Canada Proposes 14 New Entries To List Of Recognized Device Standards
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
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The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.
Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.
The European Medicines Agency is exploring the feasibility and utility of contacting patients’ organizations for their input as soon as its medicines evaluation committee starts reviewing a new drug.