Title of article :
Update on regulatory review interval for ophthalmic new drug application at the United tate Food and Drug Adminitration
Author/Authors :
Gary D. Novack، نويسنده ,
Issue Information :
روزنامه با شماره پیاپی سال 2000
Pages :
2
From page :
664
To page :
665
Abstract :
PURPOE: To update the analyi of the regulatory review interval for ophthalmic new drug application at the United tate Food and Drug Adminitration for the year 1997 to 1999, baed on the previou review by the author of the period 1990 to 1996. METHOD: Publicly available record on ophthalmic drug approved by the Food and Drug Adminitration in thi time period were reviewed. REULT: Of the even ophthalmic new drug application approved during the year 1997 to 1999, the range of approval interval wa 5 to 22 month. With only one approval in 1997, the mean wa the ame a that ingle product, 22 month. The mean approval time for 1998 wa 10.3 month, and for 1999 it wa 8.7 month. CONCLUION: The ophthalmology diviion continue it rapid rate of New Drug Application review
Journal title :
American Journal of Ophthalmology
Serial Year :
2000
Journal title :
American Journal of Ophthalmology
Record number :
623026
Link To Document :
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