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The FDA Breakthrough-Drug Designation — Four Years of Experience

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2015A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)817 cited
2017Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review121 cited
2014New FDA Breakthrough-Drug Category — Implications for Patients119 cited
2017The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-201684 cited

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2022Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland46 cited

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