Ellen Pinnow
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Author Swipe
View article: Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling
Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling Open
Introduction The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected …
View article: Trends in pediatric nonprescription analgesic/antipyretic exposures during the COVID-19 pandemic
Trends in pediatric nonprescription analgesic/antipyretic exposures during the COVID-19 pandemic Open
Nonprescription analgesic/antipyretic unintentional exposure cases declined among young children, while intentional exposure cases increased among females, 6-17 years, during the pandemic. Findings highlight the importance of safely storin…
View article: The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes Open
We characterized the size of the premarket safety population for 278 small‐molecule new molecular entities (NMEs) and 61 new therapeutic biologics (NTBs) approved by the US Food and Drug Administration (FDA) between October 1, 2002, and De…
View article: Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities
Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities Open
We examined the relationship of regulatory and review characteristics to postmarketing safety‐related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014. We also compared NTBs …