Adaptive licensing

Adaptive Drug Development and Licensing

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Understanding the Regulatory Drivers for Adaptive Design Trials

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Interview: Uniting strategy and science

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Can adaptive licensing bridge the gap between regulatory and HTA evidentiary standards?

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The prospect of a new model for drug approval based on ‘acknowledged uncertainty’ provided for a lively debate at the European Medicines Agency Review of the Year and Outlook for 2013, an annual meeting organised with TOPRA. The concept of adaptive licensing is not revolutionary, but rather a natural step in the evolution of drug approval, explained the EMA’s Senior Medical Officer, Hans-Georg Eichler. Nonetheless, not all parties were in agreement.

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