EMA, FDA Get Together On Drugs Eligible For PRIME And Breakthrough Designation
Regulators will share ideas on how to facilitate parallel discussions on products submitted under PRIME and breakthrough.
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The first four drugs European Medicines Agency selects for its new priority review program include Biogen's Alzheimer's disease treatment aducanumab. Fourteen applicants did not garner PRIME status.
Aside from pediatrics research issue, most of the first batch of applications for the new priority review scheme were "in scope," with numerous therapeutic areas targeted.
Eleven applications to the European priority review program came from smaller companies.