21 Jul FDA inspections face overhaul

The agency proposes significant revisions to oversight programs for drugs and medical products.

By Jill Wechsler, Applied Clinical Trials

As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for drugs and medical products, at home and abroad. While the current goal is to improve FDA’s capability for monitoring and curbing contamination issues involving foods, the agency also proposes significant changes in oversight and inspection programs for medicines and other regulated products. Some of the changes arise from FDA’s greater reliance on remote oversight activities during the global COVID-19 pandemic, which encouraged more cooperation with foreign inspection programs, and these are likely to continue as FDA seeks to better monitor overseas facilities in more timely and less costly ways.

A recent sign of these developments is a slight change in how the Center for Drug Evaluation and Research (CDER) selects drug manufacturing sites for inspections to ensure compliance with standards. CDER’s Office of Pharmaceutical Quality (OPQ) recently updated procedures for its risk-based site selection model to additionally include the compliance history of an establishment in the country or region where it is located. This information will be added to FDA’s existing list of risk factors for setting inspection priorities, which includes site operations, product characteristics, compliance history, past field alert reports, recalls, and other compliance issues. Read more …