CDER’s Regulatory Science Initiatives
Back to Regulatory Science at CDER
CDER has a wide range of initiatives to streamline the drug development process and ensure that new and existing drugs are safe and effective.
The 21st Century Review Initiative aims to better organize and integrate drug reviews that involve multiple offices.
The Critical Path Initiative is stimulating a national effort to modernize the process through which FDA-regulated products are developed, evaluated, and manufactured. In 2013, FDA introduced Critical Path Innovation Meetings to bring FDA staff and external researchers together for informal scientific conversations about emerging areas of treatment and new approaches to drug development.
Drug Development Tool (DDT) Qualification Programs allow CDER to guide submitters as they develop or refine a DDT, such as an animal model or biomarker, for a specific context of use. Once a DDT is qualified, sponsors can use it in the qualified context of use during development without requesting that CDER reconsider and reconfirm the drug's suitability for that context of use.
The Sentinel Initiative will bolster CDER's postmarketing surveillance program by complementing FDA's Adverse Event Reporting System. With Sentinel, FDA will have rapid and secure access to electronic health care databases, expanding FDA's ability to evaluate health data, conduct studies, and take regulatory actions to improve safety and protect the public health.
Read more about these and other initiatives at CDER.