Oncology Accelerated Approval Confirmatory Trials – FDA

FDA posted on LinkedIn about recent paper by Gautam Mehta and Richard Pazdur, titled “Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug” published on Journal of Clinical Oncology.

“Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug – via Journal of Clinical Oncology / American Society of Clinical Oncology (ASCO). FDA authors Gautam Mehta and Richard Pazdur.”

Gautam Mehta serves as the Associate Director for Oncology Clinical Policy at the FDA, where he also leads Project Confirm within the Oncology Center of Excellence. In addition, he is the Scientific Liaison for Adult Neuro-Oncology at the same center. He holds the role of Associate Editor for the Journal of Neuro-Oncology and oversees social media initiatives. He also works as a Clinical Scientist at the House Ear Institute.

Richard Pazdur is the Director of the FDA’s Oncology Center of Excellence (OCE), where he oversees the coordination of oncology product reviews. He joined the FDA in 1999 as Director of the Division of Oncology Drug Products and led the 2005 consolidation of cancer and hematologic review divisions into the Office of Hematology and Oncology Products (OHOP). In 2019, OHOP became the Office of Oncologic Diseases (OOD), where he currently serves as acting director.