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비즈니스 · 2014. 7. 15.1 분 읽기
Confidentiality of Interim Results in Cardiovascular Outcome Safety Trials; Public Hearing; Request for Comments
로컬 자동 번역 · 원본 출처 언어
요약
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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →