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- Title
Adverse event reporting for cellular therapy products: Current status and future directions.
- Authors
Loper, Kathy; Sugrue, Michele W.; Raval, Jay S.; Schwartz, Joseph Yossi; Land, Kevin; Koh, Mickey; Mengling, Thilo; Greinix, Hildegard; Halter, Jörg P.; Celluzzi, Christina M.; Chaudhri, Maysum
- Abstract
Adverse event (AE) and adverse reaction (AR) reporting are key components of patient safety and surveillance systems. Review and analysis of this data yields opportunities for process improvement, product information and interventions, and can lead to improved patient outcomes and donor safety overall. AE and AR reporting for cellular therapy products is fragmented and not well characterized in a central reference. This review article, authored by experts from various organizations, serves to summarize the current state of reporting and offers opportunities for streamlining and coordination, as well as key reference for professionals in this field.
- Subjects
UNITED States; CELLULAR therapy; SYSTEM safety; PATIENT safety; DATA analysis; DATABASES; SELF-evaluation; UNITED States. Food &; Drug Administration
- Publication
Transfusion, 2020, Vol 60, Issue 12, p2815
- ISSN
0041-1132
- Publication type
journal article
- DOI
10.1111/trf.16062