EMA Tells Companies How To Boost Their Approval Chances Under PRIME
Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.
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Just three of the 13 applications that the European Medicines Agency most recently reviewed for entry onto its priority medicines scheme made the grade.
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
Regulators, Industry Agree That Frequent Communication Is Key In Developing Breakthrough, PRIME Therapies
EU and US FDA regulators and industry share strategies for expediting the development of breakthrough and PRIME therapies.