The European Medicines Agency (EMA) plans to release a reflection paper regarding when external controls can be used to generate evidence to support regulatory decisions on drug approvals. @The agency ...
As neurological conditions expose the limits of traditional clinical endpoints, Europe’s regulators are being pushed to ...
In the reflection paper, the EMA defines NIS as a clinical study that does not fulfill the criteria that characterize a clinical trial. Clinical trials typically employ randomization, blinding, and ...
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