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Negócios · 15/07/20141 min de leitura
Confidentiality of Interim Results in Cardiovascular Outcome Safety Trials; Public Hearing; Request for Comments
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Resumo
The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →