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  1. FDA STEM Outreach, Education and Engagement

Missing Field Alert Reports: An Interactive Portal Analyzes their Distribution

Authors:
Poster Author(s)
Born, Joshua, FDA/CDER (Student); Wang, Yow-Ming, FDA/CDER (Mentor); Li, Ye FDA/CDER (Mentor)
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

The Field Alert Report (FAR) regulations found in 21 CFR 314.81(b)(1) and 314.98(b) establish an early warning system to quickly identify marketed drug products that pose potential public health hazards. Application holders for approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) must submit a FAR to FDA within three days of receiving information concerning a significant quality problem with a distributed drug product. However, FDA inspections, as documented in Establishment Inspection Reports (EIRs), sometimes reveal that facilities have failed to meet this statutory requirement. This study leverages natural language processing and statistical multiplicity tests to explore the distribution of facilities that fail to submit required FARs. An interactive portal is developed for regulatory monitoring of FAR submission failure patterns, which could be applied to ongoing quality surveillance of manufacturing facilities.

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