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Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims

Executive Summary

New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.

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US FDA staff suggest that oncology and rheumatology instruments could be leveraged or supplemented to make them fit for purpose in assessing toxicity of immunosuppressive regimens in transplant recipients.

Compliance Concerns Slow Industry Uptake Of Cancer Patient-Reported Outcomes Tool

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Will Patient-Reported Data Require New Drug Labeling Framework?

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