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Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labe...
| Formato: | Texto |
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| Lenguaje: | English |
| Publicado: |
BioMed Central
2006
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1629006/ https://www.ncbi.nlm.nih.gov/pubmed/17034633 http://dx.doi.org/10.1186/1477-7525-4-79 |