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. 2017 Dec 5;318(21):2137-2138.
doi: 10.1001/jama.2017.14896.

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

Thomas J Hwang  1 , Jonathan J Darrow  1 , Aaron S Kesselheim  1
Affiliations

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

Thomas J Hwang et al. JAMA. .

Abstract

This study uses the Drugs@FDA database to analyze clinical development times for drugs to treat serious diseases within the 4 FDA expedited programs intended to speed drug review and approval.

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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. Mr Hwang reported prior employment by Blackstone and Bain Capital, which have invested in healthcare companies. Dr Kesselheim reported receiving grant funding from the US Food and Drug Administration Office of Generic Drugs and Division of Health Communication (2013-2016). No other disclosures were reported.

Figures

Figure.
Figure.. Median Clinical Development Times for New Drugs Approved by the FDA, 2012-2016
AA indicates accelerated approval; BT, breakthrough therapy; FDA, US Food and Drug Administration; FT, fast-track; PR, priority review. Clinical development times were calculated from the date of the Investigational New Drug (IND) application to the date of FDA approval. Any expedited program means any of PR, AA, FT, or BT. Development times were not available for 2 drugs in the study cohort. Error bars indicate interquartile ranges.
See this image and copyright information in PMC

References

    1. US Food and Drug Administration Guidance for industry: expedited programs for serious conditions—drugs and biologics. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformat.... Accessed August 17, 2017.
    1. US Food and Drug Administration Novel drug approvals for 2016. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm4.... Accessed August 17, 2017.
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    1. Krishnamurti T, Woloshin S, Schwartz LM, Fischhoff B. A randomized trial testing US Food and Drug Administration “breakthrough” language. JAMA Intern Med. 2015;175(11):1856-1858. - PubMed

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