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A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based oversight proposed in the pending medtech regulatory reforms.
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases.
