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MDICx Update on CDRH Patient-Centered Initiatives

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MDICx Webinar

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MDICx – Update on CDRH Patient-Centered Initiatives

May 31, 2018 – 1 p.m. Eastern, 12 p.m. Central, 10 a.m. Pacific

CDRH has made partnering with patients an ongoing strategic priority and since 2012 has advanced a number of initiatives to make that strategic vision a reality. Join us for an update on CDRH’s patient-centered initiatives being undertaken under MDUFA IV, including the Patient Preference Initiative, the Patient Engagement Advisory Committee, and patient-reported outcomes. Hear from CDRH what they have learned from these initiatives and how they plan to continue to build on the vision of partnering with patients.

In addition, we will also hear about the AWAKE Sleep Apnea initiative, a patient-focused medical product development meeting and survey that will bring patients and caregivers affected by sleep apnea together with representatives from CDRH, the FDA’s Center for Drug Evaluation and Research, and life science companies (both pharmaceutical and medical devices). This initiative builds on productive approaches to understanding patient perspectives on diagnosis, treatment, clinical trial participation, and adherence to therapy to inform product development and regulatory decision-making.

Speakers:

Kathryn O’Callaghan, Assistant Director for Strategic Programs, CDRH

Anindita Saha, Director, External Expertise and Partnerships, CDRH

Kim McCleary, AWAKE Sleep Apnea

*By attending the MDICx Series, you are interested in learning information about MDIC, it's projects and endeavors and agree to receive our e-newsletter updates.

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