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ClinicalTrials.gov Compliance Will Improve With Time, PhRMA Suggests

This article was originally published in The Pink Sheet Daily

Executive Summary

Early stats on industry's posting rate should not be seen as evidence of a "widespread breakdown" in the system, PhRMA declares in a letter to Rep. Waxman. PhRMA believes it can reach full compliance – but suggested it may need several years to do it.

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Lack of funding and lack of an enforcement mechanism prevent the agency from taking a more active role in ensuring industry compliance with posting requirements. Sens. Johnson and Dodd appear willing to give FDA more enforcement authority.

FDA Can Post On ClinicalTrials.gov, But Unlikely To Use Authority, Agency Says

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