The Food and Drug Administration Amendments Act of 2007 (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).

There has always been a special concern that products approved for pediatric use should be safe, so we undertook to determine whether this might have led FDA to require a REMS for such products more frequently than for those products indicated only for use in adults.

Regulatory Focus 15:14-16, 2010