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Authors
Burckart, Gilbert J. https://orcid.org/0000-0003-2005-9301
Abdel-Rahman, Susan https://orcid.org/0000-0002-5815-2029
Choi, Caleb https://orcid.org/0009-0005-4882-6383
Cober, M. Petrea https://orcid.org/0000-0002-4618-4998
Cummins, James E. Jr. https://orcid.org/0009-0003-2700-0051
Fotaki, Nikoletta https://orcid.org/0000-0003-1826-7363
Gonzalez, Daniel https://orcid.org/0000-0001-5522-5686
Harris, David https://orcid.org/0000-0001-9771-0866
Parrott, Neil https://orcid.org/0000-0001-6821-7714
Patel, Hardikkumar https://orcid.org/0000-0003-3855-5549
Wu, Fang https://orcid.org/0009-0009-1485-8386
Abend, Andreas https://orcid.org/0000-0002-5638-9719
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Article History
Received: 19 November 2025
Accepted: 5 February 2026
First Online: 9 March 2026
Declarations
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: The opinions expressed in this article are those of the authors and should not be interpreted as the position of the U.S. Food and Drug Administration.
: The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. AI was used to produce a first draft of the manuscript based on the recording of the meeting.
