As the costs of drug development continue to skyrocket, discovery companies are increasingly forced to consider submission alternatives to the traditional 505(b)(1) NDA pathway. The FDA has created a series of alternative drug development pathways that offer drug developers benefits such as a reduction in the number of trials required, the ability to use public data or reference completed trials, expedited approval times or market exclusivity, each of which can potentially decrease overall development costs and timelines.
Two such alternative submission options are the 505(j) Abbreviated New Drug Application (ANDA; generic drugs) and the 505(b)(2) (drug repurposing) pathways. Ken Phelps of Camargo Pharmaceuticals Services will describe, compare and contrast each of these approval pathways and the strategic cost and time savings benefits to the sponsor associated with each. Several case studies will be provided to illustrate key points.