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- Published online June 2, 2025.
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- previous version (April 29, 2025 - 09:48).
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Author Information
- Opeyemi O. Ajayi1,
- Jackie L. Cullinan2,
- Innara Basria2,
- Madaisabel Fuentes-Arias2,
- Ashley Osuna-Najarro2,
- Sarah Johnson1,
- Talia Faison3 and
- Scott Lute2,*
- 1Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQA III), Division of Product Quality Assessment XIV (DPQA XIV);
- 2CDER, OPQ, Office of Pharmaceutical Quality Research (OPQR), Division of Pharmaceutical Quality Research VI (DPQR VI); and
- 3CDER, OPQ, Office of Pharmaceutical Manufacturing Assessment (OPMA), Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)
- ↵*Corresponding Author: CDER/OPQ/OPQR/DPQR VI, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993; E-mail: Scott.Lute{at}fda.hhs.gov