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Transcript of United States Food and Drug Administration
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UNITED STATES FOOD AND
DRUG ADMINISTRATIONPREPARED BY:VIJAY SUVAGIYA
GUIDED BY: Dr. JITENDRA PATEL
N.R.V.I.P.
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Content: -
1. History2. What is the need?3. FDA Objective
4. FDA Components5. FDA Mission6. FDA Activities7. Information For Others8. What Is New
9. References
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1. History
From the beginnings of civilization people have been concerned about the quality and safety offoods and medicines.
Regulation of food in the United States dates fromearly colonial times.
Federal controls over the drug supply began withinspection of imported drugs in 1848.
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3. FDA Objective
Betterconsumer
information .
Postmarketing
safetyCounterterrorism
New product
review
Keepwatch on
safemanufacturing and handling
Monitoringfor
new risk
Standardand
regulation
Enforcement
&correcting problem
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In short,
To promote and protect the public health byhelping safe and effective products reach themarket in a timely way.
To monitor products for continued safety afterthey are in use, and
To help the public get the accurate, science-basedinformation 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
Component Full Form Regulates
5A CBER Center For BiologicsEvaluation And Research
Biological Products
5B CDRH Center For Devices And
Radiological Health
Safety and Effectiveness of New Medical Devices Before they are
Marketed5C CDER Center For Drug
Evaluation And ResearchHealth of by Assuring Prescription and OTC Drugs are Safe andEffective
5D CSFAN Center For Food SafetyAnd Applied Nutrition
Food Supply is Safe, Sanitary, Wholesome, and Honestly Labeled, andCosmetic Products are Safe and Properly Labeled.
5E CVM Center For VeterinaryMedicine
Assure that Animal Food Products are Safe.
5F NCTR National Center ForToxicological Research
Human Toxicity
5G OC Office Of TheCommissioner
5H ORA Office Of RegulatoryAffairs
Products Comply with Appropriate Public Health Laws andRegulations.
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CBER regulates biological products to advancing the public healththrough 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 healththrough the regulation of biological and related products including
blood, vaccines, tissue, allergenic and biological therapeutics.
4A. CBER
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PRODUCTS REGULATED BY
CBERA. Blood.B. Devices.C. VaccinesD. 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 PreventDiagnoseor Treat
Monitors DevicesThroughout the
Product Life Cycle,Including
PostmarketingSurveillance System
RadiationEmitting 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, andserves 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 fieldforce, 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
Scope as follow,1. The safety of substances added to food, like food and color
additives.2. The safety of foods and ingred. developed through biotechnology.
3. Health risks associated with food borne chemical, and biologicalcontaminants.4. Regulations and activities dealing with the proper labeling of foods.5. Food industry post marketing surveillance and compliance.6. Consumer education.7. Cooperative programs with state and local governments.
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4E. CVM
The FDA's Center for Veterinary Medicine (CVM) evaluates the safety andeffectiveness of drugs used to treat animals.
Nearly 300 drugs currently on the market have been approved by the FDA for dogs, catsand horses.
CVM has two top priorities:1. Prevent the establishment of bovine spongiform encephalopathy (BSE), "mad cow
disease." &2. 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.
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4F. NCTR
All of the research performed at the National Center forToxicological Research is targeted to fulfill three strategic researchgoals in support of FDA's public health mission.
1. Risk Assessment for Regulated Products
2. Knowledge Bases that Predict Human Toxicity
3. Methods use for FDA Standard Development and Product RiskSurveillance.
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4G. OC
The Office of the Commissioner is made up of severalcomponents,
1. Ethics Program2. Good Clinical Practice Program3. Office of International Programs4. Office of Orphan Products Development5. Office of Pediatric Therapeutics6. Office of Planning7. Office of Policy
8. Office of Public Affairs9. Office of Special Health Issues10. Office of Women's Health11. Small Business Program
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4H. ORAto ensure that FDA regulated products comply with appropriate publichealth 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 andregulators
Focusing on covering products imported into the US through bordercoverage and foreign inspections.
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4I. COSMETICS
FDA is only able to regulate cosmetics after products are released tothe marketplace.
Neither cosmetic products nor cosmetic ingredients (except color
additives) are reviewed or approved by FDA before they are sold tothe public.
Includes,
I. Animal Testing for Cosmetic Products
II. Inspection of CosmeticsIII. Shelf lifeIV. Cosmetic Labeling
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II. Inspection of Cosmetics
An investigator may look for the following,1. Use of prohibited ingredients
2. Improper use of restricted ingredientsnoncompliance with requirements related tocolor additives
3. Microbial contamination
4. Failure to adhere to requirements for tamper-resistant packaging5. Deficiencies in labeling and packaging
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III. Shelf Life
No regulations or requirements under currentunited states law
Manufacturers have the responsibility todetermine 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 ordistributor
An accurate statement of the quantity of contents
Any appropriate directions for safe use andWarning statements
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5. FDA Mission
MissionStatement
FDAStrategic
Plan
FDA
CustomerServiceStandards
What
FDARegulates
WhatFDADoes Not
Regulate
LawsEnforced
ByFDA
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5A. MISSION STATEMENT
The FDA is responsible for protecting the public health byassuring 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-basedinformation they need to use medicines and foods toimprove their health.
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5C. FDA CUSTOMER SERVICE
STANDARDS
I. Customers
II. Health professionals
III. Regulated industry
IV. Other government agencies
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5D. WHAT FDA REGULATES
1. Biologics2. Product and manufacturing establishment licensing3. Safety of the nation's blood supply4. Research to establish product standards and develop
improved testing methods5. Cosmetics6. Safety7. Labeling
8. Drugs9. Product approvals10. OTC and prescription drug labeling11. Drug manufacturing standards
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Cont 12. Safety of all food products13. Medical devices14. Manufacturing and performance standards15. Tracking reports of device malfunctioning and serious
adverse reactions16. Radiation-emitting electronic products17. Radiation safety performance standards for microwave
ovens, television receivers, diagnostic18. X-ray equipment, cabinet x-ray systems (such as
baggage x-rays at airports), laser products,19. Ultrasonic therapy equipment, mercury vapor lamps, and
sunlamps20. Veterinary products
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5E. WHAT FDA DOES NOT
REGULATEAdvertisingAlcohol
Consumer ProductsDrugs of AbuseHealth InsurancePesticidesRestaurants and Grocery StoresWater
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5F. LAWS ENFORCED BY FDA
1. Federal Food, Drug and Cosmetic Act
2. Food and Drug Administration Modernization Act (FDAMA)
3. Infant Formula Act of 1980
4. Drug Price Competition and Patent Term Restoration Act of 1984
5. Medical Device Amendments of 1992
6. Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994
7. Dietary Supplement Health and Education Act of 1994
8. Food and Drug Administration Modernization Act (FDAMA) of 1997
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Cont 9. Animal Drug User Fee Act of 2003 PDF
10. Food Allergen Labeling and Consumer Protection Act of 2004
12. Federal Anti-Tampering Act
13. Sanitary Food Transportation Act
14. Bioterrorism Act of 2002
15. Public Health Service Act
16. Trademark Act of 1946
17. Controlled Substances Import and Export Act
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6. FDA Activities
1. Broad Responsibilities
2. Benefits Vs. Risks
3. Safe, Wholesome and SanitaryFood
4. Safe and Effective Medicine,Biological and Medicinal Device
5. Truthful and Informational Labels
6. Safe Cosmetics
8. Safe and Effective Animal Drugs
9. Science, Regulation and ConsumerProtection
10. Keeping Watch
11. Safe Manufacturing and Handling
12. Monitor for New Risks
13. Research
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7. Information for Others
Consumers
Patients (HIV and AIDS Activities)
Health Professionals (ClinicalTrials, Dietary Supplements &Drugs)
Health Educators (Latest FDAmedical product and health news )
State/Local Officials
Industry
Press
Women (Guide to PregnancyRegistries Menopausal Hormone
Initiative)
FDA Alumni
Teens (Birth control guide,Tobacco information)
Kids (Food Safety Quiz, Match the pair)
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Cont
DRUGS
Antidepressant Use in Children,Adolescents, and AdultsBuying Medicines OnlineCelexaCounterfeit DrugsCOX-2 Inhibitors (Vioxx, Bextra,Celebrex...)Foreign Rx DrugsOxycontinPhenylpropanolamine (PPA)Protonix
FOODS
Food SafetyFood Guide Pyramid
Hurricane and Food SafetyBioengineered FoodsColor AdditivesFoodborne IllnessHoliday Food SafetyKonjac Candy Recalls
Mercury in FishDietary Supplements
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Cont
MEDICAL DEVICES
Contact Lenses and EyeInfections
Decorative Contact LensesLASIK Eye SurgeryRadiation ProtectionWhole Body CT ScansWireless (Cell) Phones
MISCELLANEOUS
Animal CloningAntibiotic Resistance
Buying Medical ProductsOnlineCosmeticsFlu InformationPoison IvyHeart HealthLosing WeightMarijuana for Medical UseQuitting SmokingTattoos
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9. Reference
www.fda.gov www.hhs.gov
http://www.fda.gov/http://www.hhs.gov/http://www.hhs.gov/http://www.fda.gov/ -
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