IPIC Message Board - Msg: 3433375

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Biotech / Medical : IPIC

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Aug 15 3:35 PM EST

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To: Pancho Villa who wrote (1041)	2/14/1998 12:19:00 PM
From: Trey Yon	of 1359

re; FDA approval time frames Since it came up AGAIN; I went back & refreshed MY memory, here part of an FDA press release from Jan 14, 1998 (some what redacted) FDA says it speeded up approvals last year: Management reforms and new laws to modernize the whole agency helped speed 35 major new approvals to market, the agency said in a statement. ''The median approval time for last year's 121 new original drugs was 14.4 months, six percent shorter than the 15.4 months in 1996,'' the FDA said. Ten of the major approvals were for products containing substances brand-new to the American market. ''The median time for first-time approvals in 1997 was 12 months, 20 percent shorter than the median time of 15.08 months required for such approvals in 1996,' Drugs that got priority approval included Viracept, Agouron's (Nasdaq:AGPH - news) new protease inhibitor for HIV which got okayed in less than three months and Evista, Eli Lilly and Co's (NYSE:LLY - news) new osteoporosis drug, cleared in less than six months. < The trend and its implications are positive for consumers, FDA approval timeframes are clearly shortening- Trey eom>

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