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NEWS |
FDA Starts Moving on Critical Path, But Initiative Running Out of Steam
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The Critical Path Initiative is an ambitious plan to improve the process of drug discovery and approval. But so far, the U.S. Food and Drug Administration strategy has not gotten funding, and experts are concerned that a lack of money could substantially slow the effort to speed up the drug pipeline.
"There is growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, affordable, and safe medical products for patients," Richard Pazdur, M.D., director of the FDA's oncology drugs division, said during a May 2004 House hearing. "This is because the current medical product development path is becoming increasingly challenging, inefficient, and costly."
Two months earlier, an FDA report had concluded that the agency urgently needs a tool kit of new scientific and technical methods—animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques—to improve
Building a Better Process
Drop in the Bucket