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. 2023 Aug 1;6(8):e2331753.
doi: 10.1001/jamanetworkopen.2023.31753.

Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

Affiliations

Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

Alissa K Wong et al. JAMA Netw Open. .
No abstract available

Plain language summary

This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mooghali reported receiving grants from Arnold Ventures during the conduct of the study. Dr Ramachandran reported receiving grants from Arnold Ventures for the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT) during the conduct of the study; personal fees from ReAct–Action on Antibiotic Resistance Strategic Policy Program; grants from Stavros Niarchos Foundation; and grants from the US Food and Drug Administration (FDA) outside the submitted work as well as serving unpaid as Chair of the FDA Task Force for Doctors for America and as Board President for Universities Allied for Essential Medicines North America. Dr Ross reported receiving grants from Arnold Ventures during the conduct of the study and grants from the FDA, Johnson & Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) outside the submitted work as well as serving as an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Dr Wallach reported receiving grants from Arnold Ventures during the conduct of the study; grants from the National Institute on Alcohol Abuse and Alcoholism of the NIH, Johnson & Johnson, and the FDA outside the submitted work; and personal fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work. No other disclosures were reported.

References

    1. US Food and Drug Administration . Expedited programs for serious conditions: drugs and biologics. Accessed May 10, 2023. https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
    1. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016. JAMA. 2017;318(21):2137-2138. doi:10.1001/jama.2017.14896 - DOI - PMC - PubMed
    1. Brown DG, Wobst HJ, Kapoor A, Kenna LA, Southall N. Clinical development times for innovative drugs. Nat Rev Drug Discov. 2022;21(11):793-794. doi:10.1038/d41573-021-00190-9 - DOI - PMC - PubMed
    1. Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of clinical trials supporting US Food and Drug Administration approval of novel therapeutic agents, 1995-2017. JAMA Netw Open. 2020;3(4):e203284. doi:10.1001/jamanetworkopen.2020.3284 - DOI - PMC - PubMed
    1. Wallach JD, Egilman AC, Dhruva SS, et al. . Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. BMJ. 2018;361:k2031. doi:10.1136/bmj.k2031 - DOI - PMC - PubMed

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