Making patients partners

How FDA’s guidance on patient experience elevates patients to drug development partners

FDA has rolled out the first of a series of planned guidance documents aimed at creating a road map for making patient experience data integral to every phase of medical product development.

The guidance documents, which were mandated in the 21st Century Cures Act, are intended to move product developers, patient groups and other stakeholders from aggregating anecdotes to collecting scientifically solid data. FDA is encouraging all interested parties to gather patient experience earlier in the product development cycle than typically occurs, and to employ robust methods that can inform regulatory, scientific and medical decisions.

The data will supplement, not replace, town hall meetings that give patients and caregivers opportunities to speak directly to FDA officials.

In its first draft guidance in the series, Patient-Focused Drug

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