Drugs

Drug Safety-Related Regulatory Science Needs and Priorities

Since the 2011 report “Identifying CDER’s Science and Research Needs” was developed by CDER’s Science Prioritization and Review Committee, activities to identify regulatory science and research needs and priorities have continued. The Center for Drug Evaluation and Research (CDER) is engaged in many drug safety-related regulatory science efforts as well as activities by CDER’s Safety Research Interest Group to identify priority gaps that could be addressed through targeted research projects. These priorities are assessed within the broad framework of FDA’s overall regulatory science objectives and evolving needs which will help guide development of CDER’s science and research agenda.

To foster further collaboration with partners outside FDA, priority projects that would benefit from external collaborations, as well as details of seven overall drug safety-related regulatory science needs, are being communicated in the following report: Assessing CDER’s Drug Safety-Related Regulatory Science Needs and Identifying Priorities.

Page Last Updated: 03/19/2015
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