Overview of the FDA Amendments Act of 2007: Its Effect on the Drug Development Landscape

Abstract

The Food and Drug Administration Amendments Act of 2007 has improved the transparency of the clinical drug development landscape in the United States in many ways. Some of the important changes require: (a) increased public disclosure of information on clinical trials both while being conducted and during the subsequent public disclosure of the results of the trial; (b) changes to the required labeling including the development of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the product outweigh its risks in the target population; (c) a requirement to do additional drug safety studies when indicated based on the available safety data; and (d) a requirement for the performance of pediatric studies when the drug may have a potential to provide better treatment options for pediatric subjects and subsequent revision of the labeling based on pediatric studies. The act has also increased FDA's authority to mandate necessary changes.