Description of Collaborative Activity: |
The joint CC-CDER collaborative working team is aimed at developing new processes to consider exceptions to existing Center of Drug Evaluation and Research (CDER) policies and procedures for extraordinary clinical circumstances. Over the past few years, CC investigators have encountered instances in which regulatory barriers may have precluded novel pharmacological interventions for severely ill patients. Leaders at the FDA CDER became aware of the concern of some NIH intramural investigators and approached CC leadership to understand the issues. |
