Biotechs challenge FDA on approval process

08/2/2007 | Wall Street Journal, The

Some biotech companies are challenging adverse FDA rulings, arguing that the agency's standards of proof and ways of assessing efficacy should be relaxed in some cases to bring novel medicines to market. Former FDA commissioner David Kessler agrees on the need to find "creative ways of getting cancer drugs to patients even if we end up being wrong a few times."

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