While the US Food and Drug Administration Drug has quickened review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical program times, according to the Tufts Center Study of Drug Development for the Study of Drug Development.
The average time for the FDA to approve new drugs declined to 1.1 years in the 2005-07 period, but longer average clinical phase terms mean combined clinical and approval time continues to hover around eight years, according to Tufts CSDD. "Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress," said Tufts CSDD director Kenneth Kaitin, who made his comments in connection with the release of the organization's Outlook 2009 report on pharmaceutical and biopharmaceutical trends.
Factors leading to longer studies
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