EMA responds to criticism of adaptive pathway

In response to criticism from a group of doctors, EMA officials said all stakeholders involved in the agency's adaptive pathways program should agree to a legally binding, post-licensing plan to collect evidence about drugs in the program. The comments came in a (see BioCentury, June 23, 2014).

Under the pathway, a drug's label could be expanded or narrowed as evidence is gathered from additional clinical trials and real-world experience in other patient populations. ...