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, oncology scientific advisor in the
Key Takeaways
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Project Orbis and 'cluster' calls allow regulators to validate their concerns about a drug application by conferring with international colleagues.
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More than 500 applications have been submitted across the participating countries under Orbis
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