FDA Centers and Offices each play a unique and vital role in FDA’s CT and MCMi efforts. Their responsibilities are described below.
The Center for Biologics and Evaluation and Research (CBER)
oversees the safety, effectiveness, quality, and availability of biological products, including vaccines, cells, tissues, and the blood supply. CBER collaborates in facilitating product development, manufacturing, and quality for needed CBRN medical countermeasures.
The Center for Drug Evaluation and Research (CDER)
ensures that safe and effective drugs are available for preventing and treating illnesses from exposure to CBRN agents. CDER facilitates new drug development and new uses for already-approved drugs that could be used as medical countermeasures.
The Center for Devices and Radiological Health (CDRH)
ensures that safe and effective diagnostics and personal protective equipment are available for diagnosing and preventing illnesses from exposure to CBRN agents. The Center also ensures that radiation-emitting products meet radiation safety standards.
The Center for Veterinary Medicine (CVM)
ensures that animal drugs, food additives, devices, and medicated feeds are safe and effective and makes certain that animal-based food is safe.
The National Center for Toxicological Research (NCTR)
conducts scientific research related to CBRN threats, including identifying virulent biomarkers, technologies for intervention, and rapid, “field-rugged” tests that can help detect bioterrorism agents.
The Office of Regulatory Affairs (ORA)
protects consumers and enhances public health by maximizing compliance with FDA laws and regulations. It achieves this through inspecting regulated products and facilities and conducting law enforcement activities to prevent tampering with or adulteration of regulated products.
The Office of Crisis Management (OCM)
coordinates emergency/crisis response activities involving FDA-regulated products or when FDA-regulated products need to be used. It works closely with HHS, Office of the Assistant Secretary for Preparedness and Response to develop policies to help FDA respond quickly to emergency or crisis situations. It also plans and directs activities related to FDA's physical and personnel security programs.