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Combination Products Cancer Regulation

New Cancer Center Played Pivotal Role In Endomag's Success

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Executive Summary

US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products, and it also spotlights the agency's recent efforts to improve combination product reviews. Check out our Q&A with FDA's Binita Asher.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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