Update on regulatory review intervals for ophthalmic new drug applications at the United States Food and Drug Administration.

Abstract

To update the analysis of the regulatory review interval for ophthalmic new drug applications at the United States Food and Drug Administration for the years 1997 to 1999, based on the previous review by the author of the period 1990 to 1996. Publicly available records on ophthalmic drugs approved by the Food and Drug Administration in this time period were reviewed. Of the seven ophthalmic new drug applications approved during the years 1997 to 1999, the range of approval intervals was 5 to 22 months. With only one approval in 1997, the mean was the same as that single product, 22 months. The mean approval time for 1998 was 10.3 months, and for 1999 it was 8.7 months. The ophthalmology division continues its rapid rate of New Drug Application review.