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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Brander who wrote (5445)	9/3/1998 11:17:00 AM
From: Dauntless	Read Replies (2) \| Respond to of 7041

Brad - Approval times are decreasing From the FDA website: FOURTH ANNUAL PERFORMANCE REPORT Prescription Drug User Fee Act of 1992 Fiscal Year 1996 Report to Congress, December 1, 1996 Total review times for "normal" NDA submissions 1993 - 21.7 months 1994 - 18.4 1995 - 13.6 Here's the link: fda.gov I seem to clearly recall seeing a later report where the times had been reduced to less than 12 months. I believe that time is calculated from the date of submission, not acceptance. If true, a decision can be expected in less than 10 months.