Accelerated Development/Review
Accelerated development/review (Federal
Register, April 15, 1992) is a
highly specialized mechanism for speeding the development of
drugs that promise significant benefit over existing therapy for
serious or life-threatening illnesses for which no therapy
exists. This process incorporates several novel elements aimed at
making sure that rapid development and review is balanced by
safeguards to protect both the patients and the integrity of the
regulatory process.
Accelerated development/review can be used under two special circumstances: when approval is based on evidence of the product's effect on a "surrogate endpoint," and when the FDA determines that safe use of a product depends on restricting its distribution or use. A surrogate endpoint is a laboratory finding or physical sign that may not be a direct measurement of how a patient feels, functions, or survives, but is still considered likely to predict therapeutic benefit for the patient.
The fundamental element of this process is that the
manufacturers must continue testing after approval to demonstrate
that the drug indeed provides therapeutic benefit to the patient.
If not, the FDA can withdraw the product from the market more
easily than usual.