united states food and drug administration

8/12/2019 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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