EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA
EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”
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FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
EMA Bolsters PRIME Scheme With Improvements
The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.
Danon Disease Gene Therapy & TGCT Treatment Win EMA PRIME Designations
Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.