Patient-Focused Drug Development: Moving Up The Development Timeline

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 Leading Into PDUFA VI: Negotiations and 2016.”