Authors’ Reply to the Letter to the Editor by Liu and Kesselheim

Authors:
Bridget Doherty Janssen Scientific Affairs, Titusville, NJ

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Silas Martin Janssen Scientific Affairs, Titusville, NJ

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Ágnes Benedict Evidera/PPD, Vienna, Austria

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  • 1.

    Liu ITT, Kesselheim AS. Letter to the Editor: Re: “Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model”. J Natl Compr Canc Netw 2024;22:e247043.

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  • 2.

    The Food and Drug Omnibus Reform Act (FDORA) (Sec. 3210) amended Section 506(c) of the FD&C Act (21 U.S.C. 356(c)). Accessed July 10, 2024. Available at: https://www.congress.gov/bill/117th-congress/house-bill/2617/text

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  • 3.

    Chen EY, Joshi SK, Tran A, Prasad V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical trials. JAMA Intern Med 2019;179:642647.

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