Patient-Reported Outcomes For Organ Transplant Drugs Could Learn From Other Fields
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.
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Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
US FDA Mulling Core Criteria For Patient-Reported Outcomes
Agency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.
Compliance Concerns Slow Industry Uptake Of Cancer Patient-Reported Outcomes Tool
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