15 August 2016 - in pointed remarks, Germany’s cost-effectiveness watchdog has criticized an effort by European regulators to accelerate approval for new medicines based on limited evidence.

And the concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs.

At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago, the European Medicines Agency launched a specific pilot program with plans to compare initial data used for approval with so-called “real world” data, which is subsequently gathered after the medicines are in use.

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