Author(s): Pariser AR, Slack DJ, Bauer LJ, Warner CA, Tracy LA
Abstract Share this page
Abstract New drug and biologic product marketing applications submitted to FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2010 were analyzed to identify rare disease application characteristics associated with higher approval rates. The results show that approval rates were similar for rare and common disease applications. Larger company size, prior regulatory experience and priority review designation were associated with higher approval rates. The study findings show that rare disease product development is feasible, and increased interactions between product developers and FDA in early investigational phases can facilitate product development. Published by Elsevier Ltd.
This article was published in Drug Discov Today
and referenced in Journal of Biometrics & Biostatistics