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.
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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.
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.
Nine of the 70 medicines for unmet medical needs that have to date won a place on the European Medicines Agency’s PRIME scheme are now approved for sale in the EU, and two more approvals are expected soon. Meanwhile, most applications for a "priority medicine" designation are still missing the mark.