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June 14, 2007Anesthesia & Analgesia

Anesthesia & Analgesia's Policy on Off-Label Drug Administration in Clinical Trials

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Key result

Anesthesia & Analgesia established a new policy requiring FDA Investigational New Drug approval for publishing clinical trials on off-label drugs lacking adequate preclinical toxicology data.

Design

Editorial

Authors

SSSteven L. ShaferAstraZeneca (United Kingdom)

Discussion

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Implication

Requires IND for off-label trials lacking toxicology data; leaves open effects on research pace and innovation.

Key Points

Key points are not available for this paper at this time.

Cite This Study

Steven L. Shafer (2007) reported an editorial. Anesthesia & Analgesia established a new policy requiring FDA Investigational New Drug approval for publishing clinical trials on off-label drugs lacking adequate preclinical toxicology data.

synapsesocial.com/papers/6a9a1971118fe2e1e5b4fc2dhttps://doi.org/10.1213/01.ane.0000268403.38481.37
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