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Incorporating digitally derived endpoints within clinical development programs by leveraging prior work.
NPJ Digit Med. 2023 Aug 10;6(1):139. doi: 10.1038/s41746-023-00886-9.
NPJ Digit Med. 2023.
PMID: 37563201
Free PMC article.
Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the Program.
Conrad R, Taylor K, Raggio M, Harrington A, Stark G, Kish A, Bertha A.
Conrad R, et al. Among authors: bertha a.
Ther Innov Regul Sci. 2017 Jul;51(4):509-515. doi: 10.1177/2168479017696284. Epub 2017 Mar 10.
Ther Innov Regul Sci. 2017.
PMID: 30227048
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An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014.
Sharma K, Harrington A, Worrell S, Bertha A.
Sharma K, et al. Among authors: bertha a.
Ther Innov Regul Sci. 2016 Nov;50(6):697-704. doi: 10.1177/2168479016651297. Epub 2016 Jul 10.
Ther Innov Regul Sci. 2016.
PMID: 30231744
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