Is a REMS Request From FDA More Likely for Drugs and Biologics Indicated for Pediatric Use?

| 01 July 2010

The Food and Drug Administration Amendments Act of 20071(FDAAA) authorized the US Food and Drug Administration (FDA) to require that a Risk Evaluation and Mitigation Strategy (REMS) be submitted with any drug or biologic marketing application for which there are concerns about the need for special measures to ensure safe use. In the first 20 months following implementation of FDAAA on 27 March 2008, FDA required a REMS for 12 of 33 (36%) drugs approved as New Molecular Entities (NMEs) under a New Drug Application (NDA) and eight of nine (88%) new biologic products approved under a Biologics License Application (BLA).2


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