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Biotech / Medical : Zonagen (zona) - good buy?
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To: Brander who wrote (5445)9/3/1998 11:17:00 AM
From: Dauntless  Read Replies (2) 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.
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