At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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The Patient-focused Drug Development (PFDD) program was initiated at FDA from 2012- 2017 under Congressional Mandate (PDUFA V) to more systematically obtain the patient perspective on specific diseases and their treatments. PFDD meetings provide key stakeholders an opportunity to hear the patient’s voice.

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