How the 21st Century Cures Act and FDA Guidelines for Patient-Focused Drug Development Impact Real-World Research
November 8, 2018 - Toronto ON CA

Phone: 4169776555

Within the context of real-world research and the impact of the 21st Century Cures Act on current and future design and implementation strategies, this webinar will explore: The history of the 21st Century Cures Act, Section 3002 on incorporating patient experience into drug development and FDA fulfilment of these obligations to-date Key concepts from the June 2018 draft FDA guidance on Patient-Focused Drug Development (PFDD) Preliminary themes from the October public meeting on PFDD methods

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