The FDA will require Aimmune to develop a Risk Evaluation and Mitigation Strategy (REMS), as well as a “black box” warning in the prescribing information. The REMS will need FDA review and approval.
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September 16, 2019
The FDA will require Aimmune to develop a Risk Evaluation and Mitigation Strategy (REMS), as well as a “black box” warning in the prescribing information. The REMS will need FDA review and approval.
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