An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.
An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.
The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for…
View definitionAn investigational device that: Is intended as an implant and presents a potential for serious…
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