Future Science & Drug Review: FDA Closing the Gap

What is regulatory science? Who does it impact and how? In this exclusive Global Forum podcast, Dr. David Strauss, Director of the Division of Applied Regulatory Science in the FDA Office of Clinical Pharmacology, discusses intersecting advancements in regulatory, basic, and clinical science, including the model-informed drug development provisions of PDUFA VI. “The Division of Applied Regulatory Science was created to move new science into the CDER review process and close the gap between scientific innovation and drug review,” explains Dr. Strauss. “We perform mission-critical applied research and review across the translational research spectrum that includes in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. We try to focus on things where FDA can really provide unique value.” Bonus Reading: Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.