FDA has issued draft guidance to create four programs to expedite development and review of drugs intended to treat serious medical conditions. The programs were developed to ensure that patients with serious conditions receive therapy as soon as FDA can determine that the drug’s benefits outweigh the risks.
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A serious condition is defined by FDA in the draft guidance as “a disease or condition associated with morbidity that has substantial impact on day-to-day functioning.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.”
When finalized, the guidance will replace previous guidance, Fast Track Drug Development Programs—Designation, Development, and Application Review, published in 2006.