‘Breakthrough’ Drugs Get ‘Road-MaPP’ – Complete With Communication Timetable
This article was originally published in The Pink Sheet Daily
CDER Manual of Policy and Procedures describes specific actions FDA review staff will take once a product has received “breakthrough therapy” designation, with an emphasis on more meetings, more frequently.
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With full NDA and BLA submissions to FDA now growing faster than INDs and supplements, user fees are increasing more rapidly as well.
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.
In other modifications, FDA tells sponsors seeking Type A meetings – the most urgent category – that data packages must accompany the request.