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by Anne Harding

FDA UPDATE

More Compounds Failing Phase I


The Scientist 2004, 18(17):47

Published 13 September 2004

More drugs in development are failing to make it to market, according to Acting FDA Commissioner Lester M. Crawford. Historically, 14% of drugs entering Phase I have won approval, Crawford said in a speech to the Banc of America Securities Healthcare Institutional Conference on July 7, but now only 8% reach the marketplace. One-half fail in Phase III, he added, compared to one in five in the past. This has pushed the cost of developing a drug from $1.1 billion in 1995 to $1.7 billion in 2002, he says.


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