FDA EIR - Iovance Biotherapeutics, Inc. - July 13, 2023

An FDA surveillance inspection of Iovance Biotherapeutics, Inc. in San Carlos, CA, was conducted from July 10-13, 2023. This inspection, performed under the regulatory oversight of the FDA's Center for Biological Evaluation and Research (CBER) and guided by CP7348.810 for Sponsors, Contract Research Organizations, and Monitors, was associated with an Investigational New Drug (IND) application and a Biologics License Application (BLA) for a pre-market submission. The purpose was to evaluate the company's role and adherence to sponsor responsibilities for a clinical study. A key finding of the inspection was that no FDA Form 483 (Investigational Observations) was issued, indicating an absence of formal regulatory violations. The only discussion item noted was the need to update the firm's Standard Operating Procedures (SOPs) to ensure they accurately reference other sections of the document. Overall, Iovance Biotherapeutics was found to accurately reflect reported endpoint and safety data, and its sponsor responsibilities were deemed to be in compliance with required duties. No formal regulatory actions were mandated beyond the discussed SOP update.