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Bethesda North Marriott Hotel and Conference Center

Mar 18, 2014 8:30 AM - Mar 20, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

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Study Endpoints and Patient-Centered Outcomes: Payer Needs vs. Regulatory Limits

Session Chair(s)

Paul Radensky, MD

Partner

McDermott Will & Emery LLP, United States

Payers are increasingly asking for value information to support coverage and pricing decisions about new drugs and medical devices. Sometimes the data payers want do not fit squarely within the labeling of the medical product. Many were hopeful that Section 114 of FDAMA and the guidance on Patient-Reported Outcomes would reduce uncertainty about what manufacturers could communicate to payers about their products, but much uncertainty—and potential risk—remains. This talk will explore the regulatory landscape for payer communications and consider some options to bridge payer needs and regulatory limits.

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