Preceptors by Center/Office/Initiative
The FDA's Center for Biologics Evaluation and Research (CBER) protects and enhances the public health through the regulation of biological and related products including blood, vaccines, allergenic, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms) are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The FDA's Center for Food Safety and Applied Nutrition (CFSAN) has one of the agency's biggest jobs: it is responsible for the safety and labeling of 80 percent of all food (including dietary supplements) consumed in the United States-the entire food supply except for meat, poultry and some egg products, which are regulated by the U.S. Department of Agriculture. Each year, about $417 billion worth of this cornucopia comes from America's orchards, farms, lakes, and oceans, and passes through more than 136,000 registered U.S. food manufacturers, processors and warehouses. In addition, $49 billion worth of seafood, fresh produce and other foods are imported from every part of the globe. Finally, CFSAN is responsible for the safety and labeling of all cosmetics marketed in the U.S.
The Center for Tobacco Products (CTP) Director is responsible for planning, managing, directing and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act for tobacco products and reinstating the 1996 final rule. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. The law gives FDA the authority to regulate tobacco products and manufacturers - not growers. The actions outlined in the final rule are expected to have significant public health and consumer protection impact, and are among the most important issues faced by the Agency in its long and distinguished history.
NCTR conducts peer-reviewed scientific research and provides expert technical advice and training that enable FDA to make sound science-based regulatory decisions and improve the health of the American people. The research is focused towards FDA's goals: 1) to understand critical biological events in the expression of toxicity and 2) to develop and characterize methods, and incorporate new technologies to improve the assessment of human exposure, susceptibility, and risk.
About MCMi: The nation's Public Health Emergency Medical Countermeasures Enterprise9 identified FDA as one of its most critical components. Strong and dynamic FDA engagement with Enterprise partners will establish clear regulatory pathways for product innovators--based on the most advanced science--and will ultimately accelerate MCM development.
Within FDA's Office of the Chief Scientist10, the Office of Counterterrorism and Emerging Threats11 is responsible for leading the implementation of the Medical Countermeasures Initiative in close collaboration with FDA's three medical product centers--CDER12, CBER13, and CDRH14--and the Office of Regulatory Affairs15.
The Office of Regulatory Affairs (ORA) protects consumers and enhances public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products. ORA is the lead office for all FDA field programs and provides leadership on imports, inspections, regulatory analyses, and enforcement policy. ORA’s field programs support the five FDA product Centers by inspecting regulated products and manufacturers both domestically and internationally, conducting sample analyses on regulated products, and examining imported products offered for entry into the United States. ORA’s staff are dispersed throughout the United States. The laboratory analytical function of ORA is conducted in 13 laboratories located throughout the country and includes food, drug, device, and animal drug and feed analysis for microbiological, chemical, and radiological adulterants.
Regenerative medicine products have the potential to repair, replace, restore, or regenerate diseased tissues. Although these products hold promise for the treatment of a wide variety of human disorders, they may also raise some safety concerns. Among these concerns is the risk of an adverse immune response to the administered product. Such responses may vary from mild infusion reactions to life-threatening events that preclude further development of the product.