N.R.V.I.P.

UNITED STATES FOOD AND DRUG ADMINISTRATION

PREPARED BY:VIJAY SUVAGIYA GUIDED BY: Dr. JITENDRA PATEL

Content: 1. 2. 3. 4. 5. 6. 7. 8. 9.

History What is the need? FDA Objective FDA Components FDA Mission FDA Activities Information For Others What Is New References

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1. History
From the beginnings of civilization people have

been concerned about the quality and safety of foods and medicines.
Regulation of food in the United States dates from

early colonial times.

Federal controls over the drug supply began with

inspection of imported drugs in 1848.

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2. What is the need?

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3. FDA Objective

Post Better marketing consumer information. safety

Counter terrorism

Keep New watch on Monitoring product safe for review manufacturing new risk and handling

Standard and regulation

Enforcement & correcting problem

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In short,
To promote and protect the public health by

helping safe and effective products reach the market in a timely way.
To monitor products for continued safety after

they are in use, and

To help the public get the accurate, science-based

information needed to improve health

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4. FDA Components

CBER

CDRH

CDER

CFSAN

CVM

NCTR

OC

ORA COSMETICS

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Cont
Sr. No 5A 5B 5C 5D 5E 5F 5G 5H Component CBER CDRH CDER CSFAN CVM NCTR OC ORA Full Form Center For Biologics Evaluation And Research Center For Devices And Radiological Health Center For Drug Evaluation And Research Center For Food Safety And Applied Nutrition Center For Veterinary Medicine National Center For Toxicological Research Office Of The Commissioner Office Of Regulatory Affairs Products Comply with Appropriate Public Health Laws and Regulations. Biological Products Safety and Effectiveness of New Medical Devices Before they are Marketed Health of by Assuring Prescription and OTC Drugs are Safe and Effective Food Supply is Safe, Sanitary, Wholesome, and Honestly Labeled, and Cosmetic Products are Safe and Properly Labeled. Assure that Animal Food Products are Safe. Human Toxicity Regulates

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4A. CBER
CBER regulates biological products to advancing the public health

through innovative regulations that ensure the safety effectiveness and timely delivery to patients of biological products.

The mission of CBER is to protect and enhance the public health

through the regulation of biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics.

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PRODUCTS REGULATED BY CBER

A. Blood. B. Devices. C. Vaccines D. Tissue. E. Human Tissue & Cellular products. F. Allergenics.

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4B. CDRH
CDRH assure that new medical devices are safe and effective before they are marketed.

Surgical Tools

Prevent Diagnose or Treat

Monitors Devices Throughout the Product Life Cycle, Including Postmarketing Surveillance System

Radiation Emitting Products

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4C. CDER
The FDA's Center for Drug Evaluation and Research

(CDER) promotes and protects the health, by assuring that all prescription and over-the-counter drugs are safe and effective.
CDER evaluates all new drugs before they are sold, and

serves as a consumer guide for the drugs on the market to be sure they continue to meet the highest standards.

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4D. CFSAN
The Center for Food Safety and Applied Nutrition, known as CFSAN,

is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA).
The mission of CFSAN is, promoting and protecting the public's health

by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

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Cont
1. 2. 3. 4. 5. 6. 7.

Scope as follow, The safety of substances added to food, like food and color additives. The safety of foods and ingred. developed through biotechnology. Health risks associated with food borne chemical, and biological contaminants. Regulations and activities dealing with the proper labeling of foods. Food industry post marketing surveillance and compliance. Consumer education. Cooperative programs with state and local governments.

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4E. CVM
The FDA's Center for Veterinary Medicine (CVM) evaluates the safety and

effectiveness of drugs used to treat animals.

Nearly 300 drugs currently on the market have been approved by the FDA for dogs, cats

and horses.
CVM has two top priorities: 1. Prevent the establishment of bovine spongiform encephalopathy (BSE), "mad cow 2.

disease." & Counter the risk of antibiotic resistance in humans from animal food. given to animals.

CVM regulates the manufacture and distribution of food additives and drugs that will be

CVM is responsible for regulating drugs, devices, and food additives given to animals.

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4F. NCTR

All of the research performed at the National Center for Toxicological Research is targeted to fulfill three strategic research goals in support of FDA's public health mission.
Risk Assessment for Regulated Products Knowledge Bases that Predict Human Toxicity Methods use for FDA Standard Development and Product Risk Surveillance.

1. 2. 3.

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4G. OC
The Office of the Commissioner is made up of several components,
1. Ethics Program 2. Good Clinical Practice Program 3. Office of International Programs 4. Office of Orphan Products Development 5. Office of Pediatric Therapeutics 6. Office of Planning 7. Office of Policy 8. Office of Public Affairs 9. Office of Special Health Issues 10. Office of Women's Health 11. Small Business Program

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4H. ORA
to ensure that FDA regulated products comply with appropriate public

health laws and regulations.

Compliance Strategies of ORA includes, Providing information to industry

Highlighting areas of significant violations and impact on public health

Prioritizing and targeting high-risk areas Cooperating with state and local public health authorities and regulators Focusing on covering products imported into the US through border coverage and foreign inspections.
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4I. COSMETICS

FDA is only able to regulate cosmetics after products are released to the marketplace.
Neither cosmetic products nor cosmetic ingredients (except color additives) are reviewed or approved by FDA before they are sold to the public. Includes,
Animal Testing for Cosmetic Products

I.

II. Inspection of Cosmetics III. Shelf life IV. Cosmetic Labeling

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I. Animal Testing for Cosmetic Products

FDA does not mandate to do animal testing

FDA develop validated alternatives to animal

testing in assessing cosmetic safety

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II. Inspection of Cosmetics

1. 2.

3. 4. 5.

An investigator may look for the following, Use of prohibited ingredients Improper use of restricted ingredients noncompliance with requirements related to color additives Microbial contamination Failure to adhere to requirements for tamperresistant packaging Deficiencies in labeling and packaging
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III. Shelf Life

No regulations or requirements under current

united states law

Manufacturers have the responsibility to

determine shelf life for products

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IV. Cosmetic Labeling

The name of manufacturer, packer or distributor
Place of business of the manufacturer, packer or

distributor
An accurate statement of the quantity of contents Any appropriate directions for safe use and

Warning statements
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5. FDA Mission

FDA What FDA Mission Customer FDA Strategic Service Statement Plan Standards Regulates

What Laws FDA Enforced Does By Not FDA Regulate

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5A. MISSION STATEMENT

The FDA is responsible for protecting the public health by

assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, cosmetics, and products that emit radiation. information they need to use medicines and foods to improve their health.

And helping the public to get the accurate, science-based

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5B. FDA STRATEGIC PLAN

Efficient Risk Management

More Effective Regulation Through a Stronger Workforce PLAN

Improving Health Through Better Information

Protecting America From Terrorism

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Improving Patient and Consumer Safety

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5C. FDA CUSTOMER SERVICE STANDARDS

I.

Customers

II.
III. IV.

Health professionals
Regulated industry Other government agencies
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5D. WHAT FDA REGULATES

Biologics Product and manufacturing establishment licensing Safety of the nation's blood supply Research to establish product standards and develop improved testing methods 5. Cosmetics 6. Safety 7. Labeling 8. Drugs 9. Product approvals 10. OTC and prescription drug labeling 11. Drug manufacturing standards
1. 2. 3. 4.
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Cont
12. Safety of all food products 13. Medical devices 14. Manufacturing and performance standards 15. Tracking reports of device malfunctioning and serious adverse reactions 16. Radiation-emitting electronic products 17. Radiation safety performance standards for microwave ovens, television receivers, diagnostic 18. X-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, 19. Ultrasonic therapy equipment, mercury vapor lamps, and sunlamps 20. Veterinary products
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5E. WHAT FDA DOES NOT REGULATE

Advertising Alcohol Consumer Products Drugs of Abuse Health Insurance Pesticides Restaurants and Grocery Stores Water

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5F. LAWS ENFORCED BY FDA

1. 2. 3. 4. 5. 6.

Federal Food, Drug and Cosmetic Act Food and Drug Administration Modernization Act (FDAMA) Infant Formula Act of 1980 Drug Price Competition and Patent Term Restoration Act of 1984 Medical Device Amendments of 1992 Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994

7.
8.

Dietary Supplement Health and Education Act of 1994

Food and Drug Administration Modernization Act (FDAMA) of 1997

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Cont
9.
10. 12. 13. 14. 15.

Animal Drug User Fee Act of 2003 PDF Food Allergen Labeling and Consumer Protection Act of 2004 Federal Anti-Tampering Act Sanitary Food Transportation Act Bioterrorism Act of 2002 Public Health Service Act

16.
17.

Trademark Act of 1946

Controlled Substances Import and Export Act

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6. FDA Activities
1. Broad Responsibilities
2. Benefits Vs. Risks 3. Safe, Wholesome and Sanitary

8. Safe and Effective Animal Drugs

9. Science, Regulation and Consumer

Protection Food
4. Safe and Effective Medicine, 10. Keeping Watch 11. Safe Manufacturing and Handling 12. Monitor for New Risks 5. Truthful and Informational Labels

Biological and Medicinal Device

13. Research
6. Safe Cosmetics

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7. Information for Others

Consumers
Patients (HIV and AIDS Activities) Health Professionals (Clinical

Press
Women (Guide to Pregnancy

Registries Menopausal Hormone Initiative)

FDA Alumni Teens (Birth control guide,

Trials, Dietary Supplements & Drugs)

Health Educators (Latest FDA

medical product and health news )

State/Local Officials Industry

Tobacco information)
Kids (Food Safety Quiz, Match the

pair)

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8. What is New ?

MISCELLANEOUS

DRUGS

MEDICAL DEVICES

FOOD

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Cont
DRUGS
Antidepressant Use in Children,

FOODS

Adolescents, and Adults Buying Medicines Online Celexa Counterfeit Drugs COX-2 Inhibitors (Vioxx, Bextra, Celebrex...) Foreign Rx Drugs Oxycontin Phenylpropanolamine (PPA) Protonix

Food Safety Food Guide Pyramid Hurricane and Food Safety Bioengineered Foods Color Additives Foodborne Illness Holiday Food Safety Konjac Candy Recalls Mercury in Fish Dietary Supplements

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Cont
MEDICAL DEVICES
Contact Lenses and Eye

MISCELLANEOUS
Animal Cloning Antibiotic Resistance Buying Medical Products

Infections Decorative Contact Lenses LASIK Eye Surgery Radiation Protection Whole Body CT Scans Wireless (Cell) Phones

Online Cosmetics Flu Information Poison Ivy Heart Health Losing Weight Marijuana for Medical Use Quitting Smoking Tattoos
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9. Reference
www.fda.gov www.hhs.gov

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