Fast Track is a new designation by the FDA which is intended to fasten the approval process of a drug or drugs that may treat a terminal disease and completely eliminate an unmet medical need (Emergo, 2018).
Launched earlier this year, manufacturers of drugs have until the end of September to submit their applications so that they are vetted and found eligible to participate in the program (Emergo, 2018). The program is open to companies which are already in the market as well as new manufacturers. Once the manufacturers’ application is accepted, their technology and devices will undergo thorough underwriting before they are accepted.
For a fast trucked drug to be approved, it must show certain benefits when compared to the existing drug. Benefits include being most effective, little to no side effects, improve the diagnosis of a serious disease and address public health issue (Johnson, 2018).
Fast Track drugs can only be used to treat a serious condition or an unmet medical need. A serious condition is a health condition which if left untreated, it will progress to a more severe condition. An unmet medical need is a disease or condition whose therapy or treatment has not been tried. For such conditions, the type of drug used will be a preventative drug (Johnson, 2018)
EMERGO. (2018, June 7). US FDA Attempts to Spur Development of Medical Devices Targeting Opioid Addiction. Retrieved from https://www.emergobyul.com/blog/2018/05/us-fda-attempts-spur-development-medical-devices-targeting-opioid-addiction
Johnson, S. B. (2018). Regulatory Considerations. Handbook of Neuroemergency Clinical Trials, 329-359. doi:10.1016/b978-0-12-804064-5.00017-5