FDA EIR - Mitsubishi Tanabe Pharma Development America, Inc. - October 15, 2021

An FDA inspection of Mitsubishi Tanabe Pharma Development America, Inc., located in Jersey City, NJ, was conducted from October 12-15, 2021. This routine inspection assessed the firm's compliance with postmarketing adverse drug experience (PADE) reporting regulations, specifically reviewing pharmacovigilance activities for Exservan (NDA 212640) and Radicava (NDA 209176).

The inspection revealed two key issues. Firstly, the company's written procedures for reporting post-marketing adverse drug experiences lacked specific details regarding the required frequency and submission deadlines for periodic safety reports, including quarterly and annual reports, a deviation from 21 CFR 314.80(b). Secondly, the firm submitted two quarterly periodic adverse drug experience reports for Exservan late—three days and two days overdue, respectively. These delays stemmed from an incorrect calculation of reporting intervals, which the company had continued from the previous New Drug Application holder, violating 21 CFR 314.80(c)(2).

In response, management committed to reviewing and updating their written procedures to clearly define periodic safety reporting requirements and timelines. They also stated their plan to implement the correct reporting interval for all future periodic adverse drug experience reports to ensure timely submissions.