What Are Some Of The Key Components In Gaining FDA Fast Track Designation For A Therapeutic?

A | ACCORDING TO THE FDA, determining if a condition is serious is a judgment call, but in general these decisions are made based on the severity of the disease, the impact on daily function, and the likelihood of whether a condition will significantly worsen if left untreated. In securing Fast Track status for an investigational compound, a company must first describe how its therapeutic candidate will be developed to address an important shortcoming in current medical treatment. Companies securing Fast Track designation may be privy to more frequent meetings with the FDA and written correspondences aimed at expediting the approval process, and in certain cases, expanding earlier-stage access for serious conditions with no or few treatment options.

LESLIE WILLIAMS is president, CEO, and founder of ImmusanT, Inc., a clinical-stage company focused on peptide treatments for autoimmune diseases.