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FDA: Some breakthroughs faster than others

March 14, 2015 2:12 AM UTC

As the queue of breakthrough designation candidates grows longer, FDA is setting standards for determining which of the applications will get the fastest reviews.

In a new Manual of Policies and Procedures (MAPP) that took effect this week, the Center for Drug Evaluation and Research provided criteria for how review teams should determine whether drug candidates with breakthrough therapy designation will receive an "expedited review." ...