FDA’s New Pilot Program Encouraging Innovation

A Food and Drug Law Institute article entitled “FDA’s New Pilot Program Encouraging Innovation,” written by Angela Bowen and Erick Marshall, discusses the Complex Innovative Trial Designs Pilot Meeting Program, and the opportunity for sponsors with an Investigational New Drug (IND) number or pre-IND number to meet twice with the biostatistical review components of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) to discuss a complex innovative trial design for medical product development. The pilot is also intended to promote the improvement of trial designs in the broader scientific community by allowing FDA to share the trial designs publicly.