FDA Releases Report on CDER’s Drug Safety Regulatory Science Needs, Priorities

The Food and Drug Administration March 19 released a report that identifies drug safety-related regulatory science needs and priorities for the Center for Drug Evaluation and Research (CDER), including improving access to postmarket data sources and exploring their use in safety signal analyses.

The agency said it hopes to foster collaborations with external partners and stakeholders to help address these needs and priorities. In commenting on the report, stakeholders conducting research related to CDER’s needs should describe that research and indicate their interest in collaborating with the FDA to address safety-related research priorities, the notice said.

A notice announcing the ...