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Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns

 
• By Sue Sutter

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.

Global
International collaborations provide a 'reality check' for regulators about the problems they see with some drug applications. • Source: Shutterstock

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.

Given the confidentiality restrictions regulatory authorities must follow, it is reassuring to “exit our comfort zone and confront other regulators” who have assessed a drug application independently, said Francesco Pignatti,...

Key Takeaways

  • Project Orbis and 'cluster' calls allow regulators to validate their concerns about a drug application by conferring with international colleagues.

  • More than 500 applications...

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