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The purpose of this article is to provide Sponsors and CROs with a point-by-point review
of the differences between the Final FDA PRO Guidance and the Draft, highlighting the
choices made by FDA during the 3 years following the Draft PRO Guidance. These choices
reveal the FDA deliberations and resulting emphasis, and we also suggest in our review
what some of the differences might imply. Note that where terms appear highlighted
or emphasized in quotes from the Final Guidance, the emphasis has been done in the
original FDA document.