FDA EIR - Pfizer Inc. - June 28, 2017

An FDA Bioresearch Monitoring inspection of Pfizer, Inc. was conducted from June 19 to June 28, 2017, at its Groton, CT facility. This pre-market inspection, requested by the FDA's Center for Drug Evaluation and Research, focused on Pfizer's sponsor responsibilities for the operational execution of two clinical study protocols associated with an investigational new drug application (IND 106,447) and a new drug application (NDA). The inspection adhered to compliance program CP 7348.810, which outlines guidelines for sponsors, contract research organizations, and monitors. During the review of various records, including monitoring plans, reports, and serious adverse event data, a significant observation was made. At the conclusion of the inspection, a Form FDA 483 was issued to Pfizer, citing a "Failure to ensure proper monitoring of the study." This finding indicates deficiencies in how the clinical trials were overseen. The FDA's Office of Bioresearch Monitoring East (OBIMO East) recommended a classification of Voluntary Action Indicated (VAI), meaning that although a deficiency was noted, official regulatory action is not anticipated, and the firm is expected to voluntarily correct the identified issue. The case was referred to CDER for final review and classification, emphasizing the need for Pfizer to address the monitoring shortcomings to ensure clinical study integrity.