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Article: Candidate pharmaceuticals' success is 8% claims FDA
- Article from:
- Pharmaceutical Technology Europe
- Article date:
- September 1, 2004
- Author:
CopyrightCopyright Advanstar Communications, Inc. Sep 2004. Provided by ProQuest LLC. (Hide copyright information)
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Increasing complexity and toxicity increases difficulty of proving safety and effectiveness
Acting FDA commissioner, Lester M.Crawford, has revealed in a recent speech that "historically, 14% of tested products eventually cleared the hurdle of PDA's approval and entered the market place.Today.the chance of success of a candidate drug entering the Phase I trial is estimated at 8%."Crawford stressed that "this extremely high attrition rate has had two inescapable consequences - we've been getting fewer drug and biological submissions, and the development costs of these products have reached unprecedented proportions." He highlighted that filings of standard new medical entities have gone down ...