The US Food and Drug Administration (FDA) commissioned an independent review of the effects of early involvement in the drug review process. The findings, entitled Independent Evaluation of FDA’s First Cycle Review Performance–Retrospective Analysis, were released on February 7, 2006 and are available for review on the FDA website .
The review evaluated the effectiveness of drug sponsor involving FDA in the early phases of the drug review process. Results showed that 52% of sponsors that met with FDA at the end of Phase 2 trials received drug approval during the first review cycle versus on 29% of sponsors choosing not to meet with FDA. However, not all sponsors heeded FDA’s advice during these pre-submission meetings resulting in the need for multiple review cycles.
"Earlier consultation and feedback from FDA on the sponsor’s development program is critical to ensuring safe and effective study designs and increasing the probability that the resulting marketing application will meet regulatory requirements," said Acting FDA Commissioner Andrew von Eschenbach, MD. The report recommends that FDA increase its involvement throughout the development process and actively follow up with sponsors to ensure that the sponsor adequately addresses the issues identified during the pre-submission consultations.