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Prasugrel Advisory Committee Highlights FDA’s Continued Credibility Gap

Executive Summary

Controversy over a left-out member of the advisory committee for Lilly/Daiichi Sankyo's platelet inhibitor prasugrel illustrates the challenges that FDA continues to experience in ensuring the credibility of high-profile drug reviews

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FDA’s Cardio-Renal AdComm Losing Some Of Its Anticoagulant Experience

Mori Krantz and Sanjay Kaul are rotating off the committee after participating in all three reviews of J&J/Bayer’s Factor Xa inhibitor rivaroxaban, and nearly all of the meetings on novel anti-clotting agents.

FDA Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review

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J&J Xarelto Liver Profile Key To Committee Vote; New Data Offer Assurance

The FDA advisory committee review of Johnson & Johnson's anticoagulant rivaroxaban highlights a recurring regulatory issue for the agency and its expert panels: how to assess newly available data that is not included in the NDA, but could be key to a product's approvability

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