IND Safety Reports: Industry Praises FDA’s Move Towards Less Unblinding, But Wants More Flexibility
Sponsors are pleased with agency’s embrace of the ‘trigger’ approach to unblinding for safety reporting in new guidance but continue to want additional ways to keep the blind. Industry also raised concerns that parts of the guidance contradict international regulators.
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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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