The US Food and Drug Administration-led Project Orbis and other international regulatory collaborations often provide reassuring validation when a health authority is struggling with a challenging drug application, regulators said at the recent American Society of Clinical Oncology annual meeting.
Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns
Regulators from the US, Canada, European Union, Switzerland and Japan talk about the benefits of global collaboration, and reasons why they might reach different decisions on the same drug, at the American Society of Clinical Oncology annual meeting.
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