FDA EIR - Ming-Shen Dai, M.D., Ph.D. - September 27, 2019

An FDA inspection was conducted at the clinical investigator site of Ming-Shen Dai, M.D., Ph.D., Tri-Service General Hospital, Taipei City, Taiwan, from September 23 to September 27, 2019. The inspection, carried out under regulatory guidelines for clinical investigators, focused on practices related to study protocol PMA-NER-1301, sponsored by Puma Biotechnology Inc., concerning a breast cancer drug trial. The inspection identified several issues. A primary concern was stratification errors for some subjects, which stemmed from the use of local laboratory results for histology interpretations instead of central laboratory findings, leading to incorrect biomarker reporting. This misreporting affected subject stratification. Additionally, documentation regarding non-serious adverse events and their resolution was found to be incomplete. As a result of these findings, a one-item FDA Form 483, detailing inspectional observations, was issued at the close of the inspection, and the investigator subsequently provided a written response. The inspection concluded with a "Voluntary Action Indicated" classification, meaning objectionable conditions were observed but further regulatory action was not immediately justified. The findings were referred to the Center for Drug Evaluation and Research (CDER) for further review and final classification.