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. 2018 Jul 17;320(3):301-303.
doi: 10.1001/jama.2018.7619.

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

Jeremy Puthumana  1 , Joshua D Wallach  2 , Joseph S Ross  3
Affiliations

Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

Jeremy Puthumana et al. JAMA. .

Abstract

This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Wallach reported receiving grant funding from Laura and John Arnold Foundation. Dr Ross reported receiving grant funding from Laura and John Arnold Foundation, Johnson & Johnson, Medtronic, the US Food and Drug Administration, Blue Cross Blue Shield Association, Centers for Medicare & Medicaid Services, Agency for Healthcare Research and Quality, and from the National Heart, Lung, and Blood Institute of the National Institutes of Health. No other disclosures were reported.

Comment in

References

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