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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FDA Can Post On ClinicalTrials.gov, But Unlikely To Use Authority, Agency Says
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.
Clinicaltrials.gov: Rep. Waxman Wants PhRMA To Describe Steps To Improve Compliance
Waxman takes issue with PhRMA’s failure to appear at a recent House hearing to discuss FDA’s clinical trial registry. He asks the association to submit documents it has sent to member companies regarding compliance with the submission requirement.
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