![]() Lauren Tesh Hotaki is a Senior Regulatory Health Project Manager in the OCE. Currently, Dianne facilitates OCE interactions with foreign regulatory counterparts and was instrumental in the first international collaborative review between Australia, Canada, and the US under Project Orbis. From late 2005-early 2019, she was the Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products. Richard Pazdur, then the Director of the Division of Oncology Drug Products. Between 2002-2005, she served as Special Assistant to Dr. In 1993, she joined the FDA/CDER Division of Oncology and Pulmonary Drug Products as a project manager. ![]() Dianne started in 1990 as a research assistant with the Veterinary Research Program at the National Center for Research Resources, National Institutes of Health. Her government career spans 30 years, with 27 of those years with FDA oncology Divisions and Offices. She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Learn more about Project Orbisĭianne Spillman is the Associate Director for Global Regulatory Outreach in the Oncology Center of Excellence. For more information, please refer to the Project Orbis approval report. Since its inception, Project Orbis has received many oncology marketing applications and led to the approval of numerous oncology drugs for patients across the world. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States. The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.Ĭollaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval.
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