FDA EIR - Pfizer Inc. - January 12, 2017

An FDA inspection of Pfizer, Inc. in Groton, CT, was conducted from January 10 to January 12, 2017. This Premarket Biologics License Application (BLA) sponsor inspection was carried out under the Bioresearch Monitoring (BIMO) program, specifically following the guidance for Sponsors, Contract Research Organizations, and Monitors (C.P. 7348.810). The inspection focused on Protocol WS936568, a multicenter, randomized Phase 3 study evaluating the drug gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy for patients with acute myeloid leukemia (AML). This drug had previously been withdrawn from the market and was being re-evaluated for BLA 761060 based on new data. The study enrolled 280 subjects between January 2008 and April 2013. The inspection concluded with a classification of "No Action Indicated" (NAI), signifying that no adverse findings or significant issues were identified. Consequently, no FDA Form 483 was issued, and no specific corrective actions were required from Pfizer, Inc. This outcome indicates compliance with regulatory requirements during the inspected period.