Time is of the essence for patients who have serious and life-threatening conditions – especially when they have few therapeutic options. The health of these patients may not outlast the traditional drug development process.
That’s why Congress created the Fast Track designation program in 1997, with the passage of the FDA Modernization Act (FDAMA). Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions.
Over the years, the programs has become widely used by sponsors developing therapies for serious conditions. According to industry records,
the FDA received 27 requests and granted 21 in the program’s first year. In 2016, 187 requests were received and 131 were granted.
If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.