Guidance for companies considering the adaptive pathways approach
Adaptive pathways seeks to balance timely access for patients who are likely to benefit most from the medicine with the need to provide adequate evolving information on the benefits and risks of the medicine itself. The adaptive pathways concept is not meant to be applicable to all medicines, but only to medicines that are likely to offer help for a patient population with an unmet medical need, and where the criteria for adaptive pathways apply.
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