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for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance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...

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Detalles Bibliográficos
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2006
Materias:
Guidelines
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

Internet

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

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