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COAs and Regulatory Labeling Claims: Information and Limitations

March 24, 2015

Recorded Live December 12, 2013

In this video, we cover PROs through the ages and current trends, the impact of electronic versions in PRO label claims, and approvals post FDA-guidance. Our guest speakers are Paul O'Donohoe and Andrea Murison.

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

Ari Gnanasakthy discusses PRO label claims related to rare diseases, providing findings from a review of pr...

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Generating the Evidence Required for Content Validity
Generating the Evidence Required for Content Validity

Bonnie Teschendorf details the process of collecting PRO evidence to support content validity, covering asp...