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US FDA’s REMS Reluctance On Display At Recent Advisory Committees

 
• By Michael McCaughan

Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.

stopping the Dominio effect

The US FDA’s enthusiasm for the mandatory Risk Evaluation & Mitigation Strategies authority appears to have hit a new low, based on the agency’s approach during its three January advisory committee meetings.

In all three cases, the potential role for a REMS came up from the committee members – and in none of the cases did FDA seem willing to consider the...

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