Regulatory review intervals for ophthalmic new drug applications at the US Food and Drug Administration.

Abstract

To evaluate the regulatory review interval for recent ophthalmic new drug applications (NDAs) at the U.S. Food and Drug Administration (FDA). Based on publicly available information regarding submission and approval dates, the timing of FDA review of NDAs of first indications for therapeutic ophthalmic drugs in the 1990s was evaluated. The mean (median) interval of the 19 NDAs from submission to approval decreased from 44 (18) months in 1990 to 11 (10.6) months in 1996. At least nine of these agents had their first worldwide ophthalmic approval in the United States. For 10 of the 19 NDAs, the ophthalmic NDA represented the first US approval of this molecule by any route. Quality filings currently appear to be reviewed and approved in 1 year or less. Because of the confidential nature of corporate development, no analysis can be made regarding changes in the presubmission costs and timing.