The FDA Breakthrough-Drug Designation — Four Years of Experience

Jonathan J. Darrow · Jerry Avorn · Aaron Seth Kesselheim

61 citations0/0 files storedNew England Journal of Medicine

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Pharmaceutical Economics and Policy Healthcare Regulation Biomedical Ethics and Regulation

Abstract

In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of medications with potential to provide substantial improvement over existing treatments. The authors review the first 4 years of experience with this program.

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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)2017Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review 2014New FDA Breakthrough-Drug Category — Implications for Patients 2017The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

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