Regulatory review interval for ophthalmic new drug application at the U Food and Drug Adminitration Original Reearch Article

Purpoe: To evaluate the regulatory review interval for recent ophthalmic new drug application (NDA) at the U.. Food and Drug Adminitration (FDA). Method: Baed on publicly available information regarding ubmiion and approval date, the timing of FDA review of NDA of firt indication for therapeutic ophthalmic drug in the 1990 wa evaluated. Reult: The mean (median) interval of the 19 NDA from ubmiion to approval decreaed from 44 (18) month in 1990 to 11 (10.6) month in 1996. At leat nine of thee agent had their firt worldwide ophthalmic approval in the United tate. For 10 of the 19 NDA, the ophthalmic NDA repreented the firt U approval of thi molecule by any route. Concluion: Quality filing currently appear to be reviewed and approved in 1 year or le. Becaue of the confidential nature of corporate development, no analyi can be made regarding change in the preubmiion cot and timing.