Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance.
Lisa WolfDipti KalraCindy M KortepeterMonica A MuñozEileen WuGerald J Dal PanPublished in: Drug safety (2020)
Our study suggests that reports obtained from industry-sponsored programs in the Food and Drug Administration Adverse Event Reporting System database contain more data elements but are similar to non-industry-sponsored program reports with regard to 'usefulness' in signal detection.