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Latest From Hoffmann-La Roche Inc.
A senior MHRA official tells sponsors not to get "put off" by the many factors they need to examine when deciding on the suitability of decentralized trials, and instead seek early advice from regulators.
Cancer Accelerated Approval On Trial: Advisors With Conflict-Of-Interest Waivers More Likely To Support Industry
US FDA Oncologic Drugs Advisory Committee panelists who were granted financial conflict-of-interest waivers to participate in the agency’s multi-day review of accelerated approvals for three immunotherapies voted in favor of keeping the indications at issue on market more than three-quarters of the time. Non-conflicted experts voted in favor only two-thirds of the time. One of the six panel outcomes would have been different without the conflicted members’ votes.