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A Faster Finish May Depend On A Better Start – EMA's PRIME Program

 
• By Ian Schofield

EMA officials spotlight need to improve clinical development plans in the early stages, with agency exec director Rasi saying many trials are "useless." They shy away from predicting timelines or goals for quicker reviews.

Improving drug development programs in their early stages may be a key way Europe's new PRIME priority review program will help bring important drugs to market more efficiently, European Medicines Agency officials suggested at a March 7 brief to kick off the program.

While PRIME's centerpiece is earlier identification of drugs with potential to address significant unmet medical needs and accelerated review, EMA...

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More from Geography

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.