US FDA gives guidance on REMS submissions
02 October 2009
Sue Sutter
The US
FDA has given industry some long-awaited guidelines clarifying the relationships between risk evaluation and mitigation strategies (REMS) and risk minimisation action plans (RiskMAPs), detailing the contents of a REMS proposal and explaining the data submission requirements for REMS, including...
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02 October 2009
Sue Sutter
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