'Different Animals With Different Purposes': Putting PRIME And Adaptive Pathways In Context
EMA official gives perspectives on how PRIME and adaptive pathways compare, and how they fit with other programs such as conditional authorization.
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"Successful" pilot project supports integrating concepts into existing regulatory frameworks, EMA official who coordinated it says.
On March 7, the European Medicines Agency is to launch its keenly awaited PRIME (priority medicines) scheme, which is intended to support the development of medicines for patients with no treatment options or that offer a major advantage over existing drugs.
European Notebook: EMA’s 2016 Work Agenda; Clinical Trial Rule Delay; Ireland Benefits From Pfizer Merger
The European Medicines Agency wants to accelerate clinical development plans with new processes and procedures in 2016 and companies must disclose payments to providers starting mid-year; Ireland and Switzerland look set to grapple with high drug prices, and France's industry wants to reverse the erosion of jobs.