Adaptive Pathways: A Solution For Worried Payers in Europe
Executive Summary
Payers often worry about where they would stand if a drug that was approved in the context of adaptive pathways should subsequently underperform. But they should not be concerned, according to the latest discussions on this relatively new concept for getting drugs to market faster.
You may also be interested in...
Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer
Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
First-Of Kind BMS Drugs Among Myriad New Filings In EU
Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.