Different organization of US FDA and its responsibility.

1. ORGANIZATION OF US FDA
Presented by - Rovil Goel

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. 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.

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

6. 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

7. 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

8. 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

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

10. 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

11. 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.

12. 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
LaboratoriesOffice of
Communication
and Education
Office
Surveillance
and
Biometrics

13. 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.

14. 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

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

16. 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

17. 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.

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

19. 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.

20. 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

21. 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.

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

23. 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
COMMISSIONE
R
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
AFFAIRSOFFICE OF HEALTH
INFORMATICS
OFFICE OF SCIENTIFIC
PROFESSIONAL
DEVELOPMENT

24. 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.

25. 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

26. 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.

27. Food and Drug Administration Distribution of Full-Time
Equivalent (FTE) Employment Program Level
organization FY 2013 estimate
• Centre for drug evaluation and research 3603
• Centre for biologics evaluation and research 1074
• Centre for device and radiological health 1413
• Centre for food safety and applied nutrition 1082
• Centre for veterinary science 519
• Centre for tobacco products 471
• National centre for toxicological research 270
• Office of Regulatory affairs 5068
• Office of commissioner 1089
14589

28. Responsibility of FDA Organization
FDA CENTRE AREA OF RESPONSIBILITY
Centre for drug evaluation and research Safety and effectiveness of Rx 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

29. 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.

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

31. Thanks