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 Subject :USFDA's Final Guidance for Industry Patient-Reported Outcome Measures.. 2009-12-23 22:12:04 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear All,

After three years of comment review, the FDA has issued a final guidance on patient-reported outcome (PRO) instruments submitted in applications. Sponsors should define the role a PRO endpoint plays in trials so appropriate statistical methods can be planned and applied, the guidance says. The guidance revises a February 2006 draft, for which the agency received 22 comments.

Click Here for this document.

Kind regards,

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Last Edited On: 2009-12-23 22:12:04 By GCP HelpDesk for the Reason
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