FDA EIR - Pfizer, Inc. - December 05, 2014

The Food and Drug Administration (FDA) conducted a Bioresearch Monitoring (BIMO) inspection of Pfizer, Inc. (445 Eastern Point Rd, Groton, CT) from December 1 to December 5, 2014. This high-priority inspection was a CDER User Fee New Drug Application (NDA) pre-approval and sponsor monitor data validation, focusing on Pfizer's responsibilities as a sponsor under the Bioresearch Monitoring Compliance Program 7348.810. The inspection specifically reviewed the investigational drug Ibrance (palbociclib, PD 0332991) and its associated clinical study protocol A5481003 (PALOMA-1) for advanced breast cancer. During the inspection, six study sites were reviewed, and a comprehensive range of records was examined, including organizational charts, vendor oversight plans, investigator agreements, financial disclosures, monitoring plans and reports, safety reports, adverse events, protocol deviations, and standard operating procedures (SOPs). The FDA concluded that no significant deficiencies were observed during this inspection, and consequently, no FDA Form 483 was issued. The inspection confirmed the firm was following SOPs for reporting protocol deviations, addressing actions from a previous inspection. The recommended and final classification for this inspection was "No Action Indicated" (NAI), meaning no regulatory actions were required from Pfizer, Inc. based on these findings.