IND Safety Analysis Requires Broader Unblinding Of Reports, FDA Advises
This article was originally published in The Pink Sheet Daily
Sponsors should create safety assessment committees, draft guidance recommends.
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FDA’s Robert Temple says he is gratified by the way companies have implemented the agency’s guidance on IND safety reporting. Merck, AbbVie and Janssen representatives discuss issues with unblinding data and the value of an aggregate analysis at DIA’s annual meeting.
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Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.