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.
A draft guidance from the US Food and Drug Administration is recommending that pharmaceutical sponsors develop safety assessment committees that would review safety information in a drug development program and determine what information must be reported in an investigational new drug (IND) safety report.
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.