Assessing the Center of Drug Evaluation and Research's Safety-Related Regulatory Science Needs and Identifying Priorities; Report; Availability; Request for Comments

摘要

The Food and Drug Administration (FDA) is announcing the availability of a report entitled "Assessing CDER's Drug Safety- Related Regulatory Science Needs and Identifying Priorities." This report identifies drug safety-related regulatory science needs and priorities related to the mission of FDA's Center for Drug Evaluation and Research (CDER) that would benefit from external collaborations and resources. FDA hopes to foster collaborations with external partners and stakeholders to help address these needs and priorities. This notice asks stakeholders conducting research related to these needs to describe that research and indicate their interest in collaborating with FDA to address safety-related research priorities.