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Patient-Focused Drug Development: Moving Up The Development Timeline

 
• By Laura Helbling

The patient-focused drug development effort initiated in PDUFA V has been flagged as a success by FDA and industry since it began, and the program is certain to be updated as part of PDUFA VI – if not early as part of the pending 21st Century Cures bill. The key objectives shared by stakeholders: broadening and systematizing patient input, and finding ways to bring it directly into the regulatory process.

FDA, industry and patient groups appear to be on the same page when it comes to expanding the Patient-Focused Drug Development effort at FDA: the next phase involves spreading best practices to all patient organizations on how best to gather and express input to inform regulatory decisions – and for FDA to find ways to bring that input in earlier in the process for specific applications.

That was one takeaway from a panel at the Drug Information Association Annual Meeting June 15, entitled “The Growing Role of the Patient

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