In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.
The Fast Track approach to FDA expedited review is intended for drugs aimed to treat serious or life-threatening conditions and fill an unmet medical need. According to Section 506(b) of the FD&C Act, a product is eligible to be labeled as a fast track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”
Topics: FD&C Act, FDA, Fast Track
