Patient-Reported Outcome Measures Used In Medical Product Development

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for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

https://www.ncbi.nlm.nih.gov/pubmed/17034633

Patient-Reported Outcome Measures: Use in Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims

A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical...

Guidance for industry: patient-reported outcome …

https://pubmed.ncbi.nlm.nih.gov/17034633/

Abstract. This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also …

Patient-Reported Outcomes and other Clinical Outcome …

https://www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-patient-reported-outcomes-and-other-clinical-outcome-assessments

The 21st Century Cures Act (Cures Act, Public Law 114-225 ), defines clinical outcome assessment as ‘‘ (A) a measurement of a patient’s symptoms, overall mental …

Guidance for Industry

https://www.fda.gov/media/77832/download

Because the purpose of a PRO measure is to capture the patient’s experience, an instrument will not be a credible measure without evidence of its usefulness from the …

Patient-Reported Outcome Measures: Use in Medical …

https://www.hhs.gov/guidance/document/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims

Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry | Guidance Portal …

Guidance for Industry on Patient-Reported Outcome …

https://www.federalregister.gov/documents/2009/12/09/E9-29273/guidance-for-industry-on-patient-reported-outcome-measures-use-in-medical-product-development-to

This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product …

Patient-Focused Drug Development: Collecting …

https://www.fda.gov/media/139088/download

systematic approaches to collect and use robust and meaningful patient and caregiver input that can better inform medical product development and regulatory decision …

Draft Guidance for Industry on Patient-Reported …

https://www.federalregister.gov/documents/2006/02/03/E6-1433/draft-guidance-for-industry-on-patient-reported-outcome-measures-use-in-medical-product-development

FDA is announcing the availability of a draft guidance for industry entitled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support …

Patient-reported outcomes to support medical product …

https://pubmed.ncbi.nlm.nih.gov/17995471/

This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from …

Guidance for industry : patient-reported outcome measures, use …

http://link.library.in.gov/portal/Guidance-for-industry--patient-reported-outcome/wNd_R4F69Hc/

Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims Contributor Center for Biologics …