Many PRIME Applicants Are Missing Pediatric Investigation Plans
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.
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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.
European Medicines Agency will try "just as hard" to aid companies who tap into other EU regulatory tools aimed at fostering quicker reviews, official says at BIA/MHRA conference.
Regulators will share ideas on how to facilitate parallel discussions on products submitted under PRIME and breakthrough.