FDA to Deem Certain Prescription Drug Applications with Approved Risk Evaluation and Mitigation Strategies

Summary

The Food and Drug Administration (FDA) is issuing a notice to inform holders of certain prescription new drug and biological license applications that they will be automatically considered to have an approved risk evaluation and mitigation strategy (REMS) under the Food and Drug Administration Amendments Act of 2007, requiring them to submit a proposed REMS to the FDA.