USFDA organization and structure.slidesharare
- 1. ORGNIZATION AND STRUCTURE OF USFDA 1 PRESENTED BY : VISHAKHA CHAUDHARI
- 2. 2 CONTENT • FDA Overview • FDA leadership • Organization of USFDA • What does FDA regulate? • What doesn’t FDA regulate? • Organization • Responsibility of FDA centre • CDER • CBER • CDRH • CFSAN • CVM • CTP • NCTR • ORA • Challenges • Conclusion
- 3. 3 FDA Overview • Formed 1906 • Headquarters at White Oak, Maryland. • Parent agency Department of health and human services • US Department of health and human services (DHHS), regulates products accounting for roughly 25% of the united states gross national product. • The agency also has 223 field offices and 13 laboratories located throughout 50 states. • In 2008, the FDA started opening offices in foreign countries
- 4. 4 FDA Leadership • Commissioner of Food and Drugs: The head of the FDA is the Commissioner, who is appointed by the President of the United States. The Commissioner leads the agency and oversees its overall functions and operations. • Deputy Commissioner: Supports the Commissioner and may oversee specific divisions or operations within the agency. Robert M. Califf Dr. Janet Woodcock
- 5. 5 Organization of USFDA In organization of US FDA, there are six product center, one research center and two office – • CBER - Centre for biologics evaluation and research • CDRH- Centre for device and radiological health • CDER- Centre for drug evaluation and research • CFSAN- Centre for food safety and applied nutrition • CTP- Centre for tobacco products • CVM- Centre of veterinary medicine • NCTR-National center for toxicological research • ORA - office of regulatory affairs • OCI- Office of Criminal Investigations
- 6. What does FDA regulate? • Food, except for most meat and poultry products, which are regulated by U.S. department of agriculture. • Food additives • Infant formulas. • Dietary supplements. • Human drugs. • Vaccines, blood product, and other biologics. • Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers. 5
- 7. 7 What doesn’t FDA regulate? • Advertising • Alcoholic beverages • Some consumer product • Illegal drugs of abuse • Health insurance • Meat and poultry • Restaurants and grocery stores
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- 9. 9 FDA CENTER AREA OF RESPONSIBILITY Centre for biologics evaluation and research Safety and effectiveness of vaccine, nation blood supply, other biologics. Centre for device and radiological health Safety and effectiveness of medical devices, diagnostic test, radiation emitting device. Centre for drug evaluation and research Safety and effectiveness of Rx and over the counter drug. Centre for food safety and applied nutrition Safety of domestic and imported food supply cosmetics and dietary supplements Centre for tobacco products Implementation of the family smoking prevention and tobacco control act. Centre for veterinary science Safety and effectiveness of veterinary drug. Office of regulatory affairs Enforcement of laws and regulation
- 10. 10 CDER (Center for Drug Evaluation and Research) • Regulates human drugs (prescription and OTC). • Reviews drug safety and efficacy before approval. • Monitors adverse events and post-market safety. Responsibility • OTC/Prescription drugs • Biological therapeutics & generic drugs • Fluoride toothpaste, antiperspirants, dandruff shampoo, sunscreen. All are considered "drugs" by FDA.
- 11. 11 CBER (Center for Biologics Evaluation and Research) • Regulates biologics like vaccines, blood products, and gene therapies. • Ensures safety, purity, and potency of biological products. • Monitors the lifecycle of biological submissions. Responsibility • regulates biological products • CBER advances the public health. • CBER regulate the: • Allergenics • Blood • Devices • Human Tissues and Cellular • Products Vaccines, etc.
- 12. 12 CDRH (Center for Devices and Radiological Health) • Regulates medical devices (e.g., pacemakers, diagnostics). • Oversees radiation-emitting products like X-ray machines. • Reviews and clears medical devices for market use. Responsibility • Regulation of medical devices • Premarket approval and clearance • Post-market surveillance • Radiation protection • Standards and guidance • Public health education
- 13. 13 CFSAN (Center for Food Safety and Applied Nutrition) • Came in 1984 • Ensures food supply safety and proper labeling. • Regulates dietary supplements and cosmetics. • Monitors food contamination and recalls. • Regulate the proper labelling of food and cosmetic and their ingredients. • Regulate policies regarding the safety.
- 14. 14 CVM (Center for Veterinary Medicine) • Regulates animal drugs, medicated feeds, and veterinary devices. • Ensures safety of animal-derived food products. • Supports innovation in animal healthcare.
- 15. 15 CTP (Center for Tobacco Products) • Implements and enforces tobacco control laws. • Regulates manufacturing, marketing, and distribution of tobacco products. • Protects public health from tobacco-related harm.
- 16. 16 NCTR (National Center for Toxicological Research) • Conducts toxicological research to support regulatory decisions. • Focuses on safety and risk assessments. • Develops innovative methods for regulatory science.
- 17. 17 Office of Regulatory Affairs (ORA) • Handles field inspections and compliance enforcement. • Monitors manufacturing facilities for regulatory adherence. • Oversees imports and exports of regulated products.
- 18. 18 Challenges • Adapting to global regulatory variations. • Keeping up with emerging technologies (e.g., AI, personalized medicine). • Managing vast amounts of scientific and safety data.
- 19. 19 Conclusion • USFDA ensures the safety, efficacy, and quality of regulated products. • Its comprehensive structure facilitates efficient regulation. • Plays a pivotal role in protecting public health globally.
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- 21. 21 THANK YOU