FDAnews Drug Daily Bulletin

PHARSIGHT, FDA TO WORK TOGETHER ON CRITICAL PATH INITIATIVE

June 16, 2006
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The FDA has stepped up its efforts to improve the drug development process by bringing in the software firm Pharsight.

The agency and Pharsight have entered a cooperative research and development agreement (CRADA) to support the agency's Critical Path initiative, which encourages model-based drug development. The FDA will use Pharsight's software to review clinical trial data, with an emphasis on pharmacology and safety reviews.

Robert Powell, head of pharmacometrics in the FDA's Office of Clinical Pharmacology, said the CRADA is evidence of the agency's commitment to the Critical Path initiative, and that Pharsight's products will be used to apply model-based drug development skills to regulatory decisions, recommendations and knowledge-sharing.

According to a Pharsight representative, the company does not receive any payment from the FDA under the deal, but rather hopes pharmaceutical companies will want to purchase the software to have their systems consistent with the FDA's.