Regulatory Guidance

  • FDA Supports Innovation in Clinical Trials with eConsent4:12

    FDA Supports Innovation in Clinical Trials with eConsent

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  • Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!

    Understanding the EMA Oncology PRO Guideline Appendix – We Can Help!

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  • How Electronic Data Collection Helps Meet the FDA's Quality Guidelines3:05

    How Electronic Data Collection Helps Meet the FDA's Quality Guidelines

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  • Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

    Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

    Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biologic agents, and

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  • Guidance for Industry Electronic Source Data in Clinical Investigations

    Guidance for Industry Electronic Source Data in Clinical Investigations

    This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data

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

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

    This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in appro

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  • Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

    Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications

    The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and ri

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  • A Review of Patient Reported Outcome Labels in the U.S. - 2006-201355:34

    A Review of Patient Reported Outcome Labels in the U.S. - 2006-2013

    <p>Recorded Live May 15, 2014</p> <p>Analysis of PRO Evidence for Orphan Drug Label Claims</p>

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  • COAs and Regulatory Labeling Claims: Information and Limitations36:34

    COAs and Regulatory Labeling Claims: Information and Limitations

    <p>Recorded Live December 12, 2013</p>

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  • Generating the Evidence Required for Content Validity42:55

    Generating the Evidence Required for Content Validity

    <p>Recorded Live February 18, 2011</p>

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  • FDA Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Tips53:51

    FDA Guidance Compliance: Practical PRO/ePRO Instrument Equivalence Tips

    <p>Recorded live April 15, 2010</p>

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  • ePRO Devices: Practical and Regulatory Considerations46:30

    ePRO Devices: Practical and Regulatory Considerations

    <p>Recorded live May 20, 2010</p>

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  • Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR48:21

    Instrument Validation, Psychometric Testing Including a Discussion of FDA Guidance & ISPOR

    <p>(Recorded Live May 21, 2009)</p>

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