The Project Orbis initiative, which provides a framework for international partner regulators to evaluate cancer drug filings concurrently or near-concurrently with the US Food and Drug Administration, led to a 135 day reduction in the regulatory submission gap in Switzerland, according to a study published in The Lancet .
Project Orbis Led To 80% Cut In Submission Gap For Cancer Drugs In Switzerland
The international Project Orbis regulatory collaboration initiative reduced the submission gap between filings made in the US and Switzerland even more than expected, marking a step towards faster access to innovative cancer drugs, regulatory experts have told the Pink Sheet.
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