NCTROverview.pptVIP

NCTR Overview Daniel A. Casciano, Ph.D. National Center for Toxicological Research Organization of Presentation Some information on FDA Organization of the NCTR Function of SAB Center for Drug Evaluation and Research MISSION: The Center assures that safe and effective drugs are available to the American people. ISSUES: Prescription Drug User Fee Act (PDUFA), Adverse Events Reporting, Gene Therapy, Monitoring Drug Information and Advertising, Drug Quality, Drug Safety Center for Food Safety and Applied Nutrition MISSION: The Center is responsible for promoting and protecting the public’s health and economic interest by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled. The program also ensures that cosmetic products are safe and properly labeled. ISSUES: Food Safety, Joint Institute for Food Safety and Applied Nutrition, Dietary Supplements, Food Labeling, Seafood Decomposition, Phototoxicity(a Hydroxy acids) Center for Veterinary Medicine MISSION: CVM is responsible for ensuring that animal drugs and medicated feeds are safe and effective for their intended uses and that food from treated animals is safe for human consumption. ISSUES: Food Safety, Antibiotic Resistance, Aquaculture. Center for Devices and Radiological Health MISSION: The mission of CDRH is to protect the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted from electronic products (medical, industrial, and consumer). ISSUES: Reuse of Single-Use Medical Devices, Medical Device Surveillance, Medical Errors, Regulations, FDAMA, Reengineering, Device GMP Inspections, Tissue-Based Products (BSE/TSE), Genetic Assay Kits, People Scanners (X-Rays), Ultrasound, Electro-magnetic Radiation Center for Biologics Evaluation and Research MISSION: The mission of CBER is to protect and enhance the public health through regulation of biological and rel