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.
- Federal Register Notice
March 19, 2015: Assessing CDER’s Safety-Related Regulatory Science Needs and Identifying Priorities; Report
Assessing CDER's Drug Safety-Related Science Needs and Identifying Priorities (SRIG)(PDF - 245KB)
- Identifying CDER’s Science and Research Needs Report - July 2011 (PDF - 307KB)
Questions and Answers for the CDER Science and Research Needs Report Federal Register Notice
June 26, 2011: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs
FDA Center for Drug Evaluation and Research develops strategic science and research agenda[ARCHIVED]