Fast-Track Review
Fast Track is a program of the FDA that expedites the approval process for a new health technology that fulfills an unmet medical need. The biologic must either provide a new disease therapy or perform significantly better than the existing treatments. This program is not targeted at global health needs specifically, but includes an expansive range of diseases from HIV/AIDS to Diabetes. Developers participating in the Fast Track program have on-going correspondence with the FDA so that clinical trials gather the most relevant data, can abbreviate clinical trials by using surrogate markers that are likely to predict clinical effect, and can submit individual pieces of an application for rolling review. The accelerated process reduces the end stage cost of product development for drug companies.
FDA