BioCentury
ARTICLE | Politics & Policy

EMA defends Adaptive Pathways

December 10, 2016 1:08 AM UTC

EMA defended its Adaptive Pathways program on Thursday amid concerns from payers and technology assessment bodies that it could lower the evidentiary standards for drug approvals.

In 2014, EMA launched a pilot of Adaptive Pathways, which allows companies to market new products for limited, high unmet need populations based on promising early data, followed by iterative approvals for additional populations based on postmarket trials and real-world data. ...

BCIQ Company Profiles

European Medicines Agency (EMA)