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ビジネス · 2025/12/161 分で読めます
Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability
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概要
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies." The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. This guidance finalizes the draft guidance of the same title issued on June 28, 2021.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →