![]() ![]() ![]() Potential applications appropriate for this pilot are either identified by the FDA or can be suggested by companies and then reviewed by the FDA for appropriateness for inclusion in the project. What are the types of applications considered for Project Orbis and the general review process? With a framework for near-concurrent submission and review of oncology drugs, Project Orbis facilitates a collaborative review to identify any regulatory divergence across review teams at each participating agency. ![]() Development of anticancer therapies may be slowed due to varying standards of care across the world, and this can impact the design and conduct of trials. Further drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.Ĭollaboration among international regulatory agencies may allow patients with cancer to receive earlier access to products in other countries, where there may be significant delays in regulatory submissions. Pivotal clinical trials in oncology are commonly conducted internationally, and these global trials are important for investigating the safety and effectiveness of cancer drugs for approval in the United States. This “oncology cluster” was progressively expanded to include Health Canada (HC), Japan’s Pharmaceuticals and Medical Devices Agency, Australia’s Therapeutic Goods Administration (TGA), and Swissmedic (SMC). In 2004, the FDA’s Office of Hematology and Oncology Products, now known as the Office of Oncologic Diseases, 1 and the European Medicines Agency began holding regular teleconferences under a confidentiality agreement to allow for exchange of information and collaboration on specific topics related to applications under review. A key goal of this project is to accelerate the availability of novel cancer treatments to patients globally.ĭid the FDA have international collaborations before the formation of Project Orbis?Īlthough the Project Orbis initiative was formed recently, collaboration with international agencies and the FDA has been ongoing for many years. Project Orbis was initiated in May 2019 by the OCE with a vision to provide a framework for concurrent submission and review of oncology products among international partners. ![]()
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