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united states food and drug administration ppt


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Content: - : 

26 April 2012 2 Content: - History What is the need? FDA Objective FDA Components FDA Mission FDA Activities Information For Others What Is New References

1. History : 

26 April 2012 3 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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26 April 2012 4 2. What is the need?

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26 April 2012 5

In short, : 

26 April 2012 6 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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26 April 2012 7

Cont… : 

26 April 2012 8 Cont…

4A. CBER : 

26 April 2012 9 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. 4A. CBER


PRODUCTS REGULATED BY CBER A. Blood. B. Devices. C. Vaccines D. Tissue. E. Human Tissue & Cellular products. F. Allergenics. 26 April 2012 10

4B. CDRH : 

26 April 2012 11 4B. CDRH

4C. CDER : 

26 April 2012 12 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.

4D. CFSAN : 

26 April 2012 13 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.

Cont… : 

26 April 2012 14 Cont… 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.

4E. CVM : 

26 April 2012 15 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: Prevent the establishment of bovine spongiform encephalopathy (BSE), "mad cow disease." & Counter the risk of antibiotic resistance in humans from animal food. CVM regulates the manufacture and distribution of food additives and drugs that will be given to animals. CVM is responsible for regulating drugs, devices, and food additives given to animals.

4F. NCTR : 

26 April 2012 16 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.

4G. OC : 

26 April 2012 17 4G. OC The Office of the Commissioner is made up of several components, Ethics Program Good Clinical Practice Program Office of International Programs Office of Orphan Products Development Office of Pediatric Therapeutics Office of Planning Office of Policy Office of Public Affairs Office of Special Health Issues Office of Women's Health Small Business Program

4H. ORA : 

26 April 2012 18 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.


26 April 2012 19 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 Inspection of Cosmetics Shelf life Cosmetic Labeling

I. Animal Testing for Cosmetic Products : 

26 April 2012 20 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

II. Inspection of Cosmetics : 

26 April 2012 21 II. Inspection of Cosmetics 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 tamper-resistant packaging Deficiencies in labeling and packaging

III. Shelf Life : 

26 April 2012 22 III. Shelf Life No regulations or requirements under current united states law Manufacturers have the responsibility to determine shelf life for products

IV. Cosmetic Labeling : 

26 April 2012 23 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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26 April 2012 24


26 April 2012 25 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. And helping the public to get the accurate, science-based information they need to use medicines and foods to improve their health.


26 April 2012 26 5B. FDA STRATEGIC PLAN


26 April 2012 27 5C. FDA CUSTOMER SERVICE STANDARDS Customers Health professionals Regulated industry Other government agencies


26 April 2012 28 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 Cosmetics Safety Labeling Drugs Product approvals OTC and prescription drug labeling Drug manufacturing standards

Cont… : 

26 April 2012 29 Cont… 12. Safety of all food products Medical devices Manufacturing and performance standards Tracking reports of device malfunctioning and serious adverse reactions Radiation-emitting electronic products Radiation safety performance standards for microwave ovens, television receivers, diagnostic X-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, Ultrasonic therapy equipment, mercury vapor lamps, and sunlamps Veterinary products


26 April 2012 30 5E. WHAT FDA DOES NOT REGULATE Advertising Alcohol Consumer Products Drugs of Abuse Health Insurance Pesticides Restaurants and Grocery Stores Water


26 April 2012 31 5F. LAWS ENFORCED BY FDA 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 Dietary Supplement Health and Education Act of 1994 Food and Drug Administration Modernization Act (FDAMA) of 1997

Cont… : 

26 April 2012 32 Cont… 9. 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 Trademark Act of 1946 Controlled Substances Import and Export Act

6. FDA Activities : 

26 April 2012 33 6. FDA Activities Broad Responsibilities Benefits Vs. Risks Safe, Wholesome and Sanitary Food Safe and Effective Medicine, Biological and Medicinal Device Truthful and Informational Labels Safe Cosmetics Safe and Effective Animal Drugs Science, Regulation and Consumer Protection Keeping Watch Safe Manufacturing and Handling Monitor for New Risks Research

7. Information for Others : 

26 April 2012 34 7. Information for Others Consumers Patients (HIV and AIDS Activities) Health Professionals (Clinical Trials, Dietary Supplements & Drugs) Health Educators (Latest FDA medical product and health news ) State/Local Officials Industry Press Women (Guide to Pregnancy Registries Menopausal Hormone Initiative) FDA Alumni Teens (Birth control guide, Tobacco information) Kids (Food Safety Quiz, Match the pair)

8. What is New ? : 

26 April 2012 35 8. What is New ?

Cont… : 

26 April 2012 36 Cont… DRUGS Antidepressant Use in Children, Adolescents, and Adults Buying Medicines Online Celexa Counterfeit Drugs COX-2 Inhibitors (Vioxx, Bextra, Celebrex...) Foreign Rx Drugs Oxycontin Phenylpropanolamine (PPA) Protonix FOODS 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

Cont… : 

26 April 2012 37 Cont… MEDICAL DEVICES Contact Lenses and Eye Infections Decorative Contact Lenses LASIK Eye Surgery Radiation Protection Whole Body CT Scans Wireless (Cell) Phones MISCELLANEOUS Animal Cloning Antibiotic Resistance Buying Medical Products Online Cosmetics Flu Information Poison Ivy Heart Health Losing Weight Marijuana for Medical Use Quitting Smoking Tattoos

9. Reference : 

26 April 2012 38 9. Reference

Slide 39: 

26 April 2012 39 Thank You

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