Patient-Focused Drug Development High On Industry’s List Of PDUFA VI Tweaks

BIO and PhRMA want patient input gathered through a more structured and data-driven process than the current disease area meetings under PDUFA V, which are “anecdotal” in nature; National Organization for Rare Disorders seeks an interactive portal between patient community and FDA reviewers.

Broadening FDA efforts to solicit patient input and clarifying how such information will be used to inform drug development and regulatory decision-making are among the biopharmaceutical industry’s early goals for the next reauthorization of the Prescription Drug User Fee Act.

During a Sept. 23 FasterCures meeting on benefit/risk and patient-centered decision-making, representatives from the Pharmaceutical Research and Manufacturers of America...

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