September 24, 2018Regulatory
Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible:
A. Priority Review
B. Breakthrough Therapy
C. Accelerated Approval
D. Fast Track
Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Breakthrough Therapy is a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
Accelerated Approval allows drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.
A Priority Review designation means that FDA's goal is to take action on an application within 6 months.