
FDA Creates Programs to Expedite Drug Development
Programs assist in the fast track of drugs for serious conditions.
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FDA has issued
The guidance document provides a single resource for the programs, which include fast-track designation, breakthrough-therapy designation, accelerated approval, and priority-review designation. The guidance also includes threshold criteria for applicable drug candidates.
A serious condition is defined by FDA in the draft guidance as “a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible if it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.”
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