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History
- Received January 6, 2025
- Accepted March 17, 2025
- Published online April 29, 2025.
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Copyright © 2025, Parenteral Drug Association
Author Information
- Opeyemi O. Ajayi (opeyemi.ajayi{at}fda.hhs.gov)1,
- Jackie L. Cullinan2,
- Innara Basria2,
- Madaisabel Fuentes-Arias2,
- Ashley Osuna-Najarro2,
- Sarah Johnson1,
- Talia Faison3 and
- Scott Lute (Scott.Lute{at}fda.hhs.gov)2
- 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)
- 3CDER, OPQ, Office of Pharmaceutical Manufacturing Assessment (OPMA), Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)
- Corresponding author: Scott Lute, CDER/OPQ/OPQR/DPQR VI, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993. Scott.Lute{at}fda.hhs.gov
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