IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
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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.
Sponsors should create safety assessment committees, draft guidance recommends.
Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.