organizaton of usfda Regulatory affairs.

USFDA

1. ORGANIZATION OF US FDA Dept. of Pharmaceutics & RA Dr.Prakash Goudanavar

2. Table of content : FDA overview Role of FDA what does regulate what doesn’t regulate US FDA organization and their work FTE Employment Program Level Responsibility of FDA organization Responsibility of FDA

3. FDA OVERVIEW Formed 1906 Headquarters at White Oak, Maryland. Parent agency Department of Health and Human Services (DHHS) 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 the 50 states. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

4. The United States  Food and Drug Administration (FDA)  was first created to enforce the  Pure Food and Drug Act of 1906 . The Jungle  (1906) report which detailed the abysmal working conditions in a Chicago meatpacking plant where  rotten meat and poisoned rats were knowingly ground-up, canned, and sold to consumers . FDA is the major government agency involved in the oversight of prescription medications, including how these are advertised to the public .

5. History The original   Food and Drugs Act    of 1906  was passed by Congress on June 30th and signed by President Theodore Roosevelt, created to  prevent the “manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious food, drugs, medications, and liquors ...” 1911-A loophole in the Pure Food and Drug Act is discovered when the Supreme Court ruled in  U.S. v. Johnson  that the  1906 Food and Drugs Act does  not  prohibit  false therapeutic claims  but only  false and misleading statements about the ingredients   or identity of a drug . 1912-Congress enacts the   Sherley Amendment   to overcome the ruling in U.S. v. Johnson. The  Sherley Amendment  provided language that  prohibited the intentional labeling of medication bottles or packaging with false therapeutic claims . 1914-The   Harrison Narcotic Act   requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics . 1937-Elixir of Sulfanilamide , containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, highlighting the  need to establish drug safety before marketing  and to enact the pending food and drug law.

6. 1938-The   Federal Food, Drug, and Cosmetic (FDC) Act of 1938   is passed by Congress to strengthen the FDA's regulating authority. 1941-The   Insulin Amendment   is encacted , authorizing the FDA to  test and certify purity and efficacy of this lifesaving drug for diabetes    1951-The  Durham-Humphrey Amendment  goes into effect. This amendment  defines the types of medications that cannot be safely used without medical supervision and  mandates certain drugs be made availbale by prescription only . 1962-Kefauver-Harris Drug Amendments  are passed to ensure medication efficacy and greater safety. For the first time, drug manufacturers are required to  prove to FDA the effectiveness of their products  before advertising them . 1970-FDA requires  the first  patient package insert .  Oral contraceptives  must contain information for the patient about specific risks and benefits. 1997-The   FDA Modernization Act of 1997  was a major legislative act meant to reform the regulation of food, medical products, and cosmetics in more nuanced ways.

7. 2011-The FDA's  Office of Prescription Drug Promotion  (OPDP) opens. 2012 ( Food and Drug Administration Safety Innovations Act  (FDASIA ) 2017 ( Food and Drug Administration Reauthorisation Act (FDARA) )

8. What does FDA Regulate ? Foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture. Food additives. Infant formulas. Dietary supplements. Human drugs. Vaccines, blood products, and other biologics. Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers.

9. What doesn’t FDA regulate ? Advertising. alcoholic beverages. some consumer products. illegal drugs of abuse. health insurance. meat and poultry. Restaurants and grocery stores.

10. Organization of US FDA In organization of US FDA ,there are six product centre ,one research centre 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 centre for toxicological research ORA – office of regulatory affairs OCI- Office of Criminal Investigations

11. Office of commissioner office of the chief scientist Office of the food and veterinary medicine Office of the global regulatory operation and policy Office of the medical product and tobacco National centre for toxicological research Centre for food safety and applied nutrition Centre of veterinary medicine Office of regulatory affairs Centre for drug evaluation and research Centre for device and radiological health Centre for tobacco products Centre for biologics evaluation and research

12. Center for Veterinary Medicine Director Office of Minor Use and Minor Species Animal Drug Development Office of Research Office of Management Office of New Animal Drug Evaluation Office of Surveillance and Compliance

13. Role of CVM Drug for animal use . Animal food. Veterinary device .

14. Center for Biologics Evaluation and Research   Director Office of Vaccines Research and Review Office of Blood Research and Review Office of Compliance and Biologics Quality Office of Management Office of Tissues and Advanced Therapies  Office of Communication, Outreach and Development Office of Biostatistics and Epidemiology

15. Center for Biologics Evaluation and Research (CBER) regulates biological products CBER advances the public health. legal authority are : Public Health Service Act and the Federal Food, Drug and Cosmetic Act CBER regulate the : Allergenics Blood Devices Human Tissues and Cellular Products Vaccines , etc.

16. Center for Devices and Radiological Health Director Office of Device Evaluation Office of Compliance Office of Management Office of In Vitro Diagnostics and Radiological Health Office of Science and Engineering Laboratories Office of Communication and Education Office Surveillance and Biometrics

17. Role of CDRH to regulate the : Manufacturing and performance standard for device . Tracking report of device malfunctioning and serious adverse reaction . Oversee radiation safety on non-medical device that emit electromagnetic radiation cell phone , microwave, sunlamp etc.

18. Center for Tobacco Products Director Office of Management Office of Compliance and Enforcement Office of Science Office of Health Communication and Education Office of Regulations

19. Responsibility of CTP Tobacco Control Act, passed in 2009 regulating the tobacco products such as Cigarettes/cigar ,smokeless tobacco . Improving Public Health .

20. Center for Food Safety and Applied Nutrition Director Office of dietary supplement Office of regulations , policy and social science Office of management Office of regulatory science Office of cosmetic and colors Office of food safety Office of analytics and outreach Office of food nutrition and labeling Office of applied research and safety assessment Office of compliance Office of food additive safety

21. CFSAN Came in 1984. Regulate the food supply ,cosmetics and dietary supplements. Regulate the proper labelling of food and cosmetic and their ingredients. Regulate policies regarding the safety. Monitor substance added to food for safety.

22. National Center for Toxicological Research Director, Deputy Director Office of Management Office of Research Office of Scientific Coordination

23. NCTR Established in 1971. outside the Washington D.C. reduce risks associated with FDA-regulated products. NCTR strategic plan : NCTR strategic goal 1:support public health. NCTR strategic goal 2:Promote global interactions in regulatory science. NCTR strategic goal 3:develop new communication.

24. OFFICE OF REGULATORY AFFAIRS Office of The Associate Commissioner for Regulatory Affairs Office of Human & Animal Foods Operations Office of Communications & Project Management Office of Management Office of Criminal Investigations Office of Enforcement & Import Operations Office of Partnerships & Operational Policy Office of Medical Products & Tobacco Operations Office of Regulatory Science Office of Training, Education, & Development

25. Office of regulatory affairs lead office for all FDA field activities. public health is advanced and protected. Responsibility: Inspections of firms and plants producing FDA-regulated products. Investigations of consumer complaints, emergencies and criminal activity. Enforcement of FDA regulations. Sample collection and analysis. Review of imported products.

26. Office of Criminal Investigations OCI protects the American public. OCI investigates the : Cyber Crime Prescription Drugs Foods, Dietary Supplements Medical Devices Tobacco

27. OFFICE OF THE COMMISSIONER Commissioner of Food and Drugs OFFICE OF THE CHIEF SCIENTIST OFFICE OF COUNTER-TERRORISM AND EMERGING THREATS OFFICE OF EXTERNAL AFFAIRS OFFICE OF REGULATORY SCIENCE AND INNOVATION OFFICE OF MINORITY HEALTH OFFICE OF WOMEN’S HEALTH OFFICE OF COUNSELOR TO THE COMMISSIONER OFFICE OF THE CHIEF COUNSEL OFFICE OF THE EXECUTIVE SECRETARIAT OFFICE OF LABORATORY SCIENCE AND SAFETY OFFICE OF MEDIA AFFAIRS OFFICE OF COMMUNICATIONS OFFICE OF SCIENTIFIC INTEGRITY OFFICE OF HEALTH AND CONSTITUENT AFFAIRS OFFICE OF HEALTH INFORMATICS OFFICE OF SCIENTIFIC PROFESSIONAL DEVELOPMENT

28. OFFICE OF THE COMMISSIONER The commissioner is appointed by the president of united state. Which provide : leadership direction to FDA product centre ,research centre and office of regulatory affairs.

29. Center for Drug Evaluation and Research Office of management Office of centre director Office of surveillance and epidemiology Office of translational science Office of executive program Office of strategic programs Office of generic drugs Office of new drug Office of pharmaceutical quality Office of compliance Office of regulatory policy Office of communication Office of medical policy

30. Role of CDER OTC/Prescription drugs Biological therapeutics & generic drugs Not just medicine Fluoride toothpaste, antiperspirants, dandruff shampoo, sunscreen. All are considered “drugs” by FDA.

31. Responsibility of FDA Organization FDA CENTRE AREA OF RESPONSIBILITY Centre for drug evaluation and research Safety and effectiveness of R x and over the counter drug. 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 food safety and applied nutrition Safety of domestic and imported food supply ,cosmetics and dietary supplements Centre for veterinary science Safety and effectiveness of veterinary drug. Centre for tobacco products Implementation of the family smoking prevention and tobacco control act. National centre for toxicological research Research to support regulatory decision and reduce risks associated with FDA-regulated products

32. FDA CENTRE AREA OF RESPONSIBILITY Office of Regulatory affairs Enforcement of laws and regulation Office of commissioner Which provide leadership and direction to FDA product centre ,research centre and office of regulatory affairs.

33. Responsibility of FDA Protect the public health. Advancing the public health. Safety and efficacy of the drug.

34. Thanks