Breakthrough Designation Is A Two-Way Street, FDA Cautions Sponsors
Sponsors of would-be breakthrough therapies need to move as quickly as FDA is acting, from responding to emails to ramping up manufacturing so they can start trials earlier.
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Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
CDER Director Woodcock notes breakthrough program often pushes sponsors to modernize production processes.
Hoping for 'convergence' with FDA's breakthrough program, EU's PRIME designation could be offered to subset of medicines that qualify for current accelerated assessment pathway.