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FDA Week - 09/08/2017

FDA Plans Meeting On Patient Experience In Rare Disease Drug Development

September 07, 2017
FDA will address ways to incorporate patients' experiences into the development of drugs to treat rare diseases at a public workshop next month that aligns with the patient-focused drug development goals in the 21st Century Cures Act. Attendees will observe case studies "demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development," states an agency notice announcing the meeting. The Oct. 30 meeting will "aid in bridging the gap between rare disease patients' stories...


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