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

An FDA inspection was conducted at the clinical investigator site of Principal Investigator Ming-Shen Dai, M.D., Ph.D., located at Tri-Service General Hospital in Taipei City, Taiwan, from September 23-27, 2019. This pre-announced inspection, performed under the regulatory framework of CP 7348.811 pertaining to Clinical Investigators and Sponsor-Investigators, focused on the site's conduct of the NALA study protocol for Puma Biotechnology Inc. The inspection revealed several critical deficiencies. It was found that the site incorrectly reported biomarker-positive subjects by utilizing local laboratory results instead of the required central laboratory interpretations, leading to errors in subject stratification. Furthermore, the documentation for non-serious adverse events and their subsequent resolution was incomplete, indicating a lack of thorough record-keeping for patient safety information. In response to these findings, a one-item FDA Form 483 was issued to the investigator at the conclusion of the inspection. The investigator provided a written response to address the observations. The inspection resulted in a "Voluntary Action Indicated (VAI)" classification, signifying that while formal regulatory action may not be immediately necessary, potential violations were observed, and the matter has been referred to the Center for Drug Evaluation and Research (CDER) for further review and final classification.