The U.S. Food and Drug Administration (FDA) has published a new organizational structure. The June 3rd Federal Register notice described the FDA new organizational structure changes which aim to make the FDA, “more efficient, nimble, and ready for the future with the ever-changing and complex industries we regulate, including the emergence of new food and medical product technologies, the impacts of globalization, climate change and other factors that require FDA to quickly adapt to a consistently evolving world.” The agency anticipates the FDA new organizational structure taking effect October 1st. Of note in the new structure, the Office of Regulatory Affairs (ORA) will be renamed as the Office of Inspections and Investigations (OII), “and establish new inspection and investigation offices to focus on inspections, investigations, and imports as its core mission.”
The FDA new organizational structure will also:
- “realign ORA’s laboratory safety functions and resources as well as the Medical Product and Specialty Laboratories safety functions and resources to the Office of the Chief Scientist (OCS);”
- realign emergency response functions and resources from the Office of Operations’ Office of Security and Emergency Management to OII;
- realign ORA’s compliance functions to [the] Center for Biologics Evaluation and Research’s (CBER) Office of Compliance and Biologics Quality, [the] Center for Devices and Radiological Health’s Office of Product Evaluation and Quality, [the] Center for Drug Evaluation and Research’s Office of Compliance and its substructure organizations;
- merge the Office of Counter-Terrorism and Emerging Threats, and the Office of Regulatory Science and Innovation, to form the Office of Regulatory and Emerging Science. Establish the Communications and Outreach Staff, the Preparedness Research Staff, and the Regulatory Science Staff to this new organization;
- establish the Office of Specialty Laboratories and Enforcement Support and realign functions from ORA’s Office of Medical Products Laboratory Operations within the Office of Regulatory Science to this new organization which will be a direct report to OCS; [and]
- establish the Office of Science and Laboratory Advancement and realign functions from ORA’s Office of Safety within the Office of Regulatory Science to this new organization which will be a direct report to OCS.”
The announcement also explained that, “the Office of Compliance and Biologics Quality within CBER is headed by the Director for Compliance and Biologics Quality [and will include the] Blood and Tissue Compliance Branch [and] Laboratory of Blood Related Products Branch [as part of its organizational units.]”