Prasugrel Advisory Committee Highlights FDA’s Continued Credibility Gap
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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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 offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.
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