In announcing major changes to the agency’s oversight of foods and nutritional products, FDA Commissioner Robert Califf cited the need to “transform” the agency’s field inspection operation. The contemplated realignment of the Office of Regulatory Affairs (ORA) would better focus this vast organization on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices. And more unified oversight for human foods will aim to clarify lines of authority between FDA centers and the agency’s investigational force of some 5000 staffers in more than 200 offices and 13 labs around the country.
