IPR USFDA

1. United State Food & Drug
Administration
Presented by:
Madhu k S
1st M pharma
Dept,of industrial pharmacy
Srinivas college of pharmacy
Mangalore.

2. Content:
• Introduction
• Mission /Role of USFDA
• Objectives , scope
• FDA Strategic plan
• FDA Organization
• Products Regulated by FDA
• What FDA doesn’t Regulate
• Laws enforced by FDA
• FDA globalisation
• FDA in India
• Functions
• Reference
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3. INTRODUCTION
▪ The U.S. Food and Drug Administration
(FDA or USFDA) is a science-based
regulatory agency within the U.S.
Department of Health and Human Services
(HHS) – Food and Drug Administration Act
of 1988.
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4. MISSION/ROLE OF USFDA
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▪ 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, nation’s food supply,
cosmetics, and products that emit radiation.
▪ The FDA is also responsible for advancing the public health by
helping to speed innovations that make medicines and foods more
effective, safer, and more affordable; and helping the public get
the accurate, science-based information they need to use
medicines and foods to improve their health.
▪ To participate with representatives of other countries to reduce the
burden of regulation, coordinate regulatory requirements, and
achieve appropriate equivalent arrangements. 4

5. OBJECTIVES
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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.
 To Help the public get the accurate, science-based information needed
to improve health.
OBJECTIVES
 To provide safe and effective Medicine, Biological and Medicinal
devices.
 To provide safe, effective and sanitary Food.
 To provide truthful and informative label.
 To provide safe and effective Animal Drugs.
 For facilitating safe consumer and Medical Radiation products.
SCOPE
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7. FDA STRATEGIC PLAN
PLAN
Efficient Risk
Management
Improving Health
through Better
Information
Improving Patient
and Consumer
Safety
Protecting America
From Terrorism
More Effective
Regulation Through a
Stronger Workforce
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8. FDA-Organisations
 The Office of Criminal investigation(OCI)
 The Center for Drug Evaluation and Research (CDER)
 The Center for Biologics Evaluation and Research (CBER)
 The Center for Food Safety and Applied Nutrition (CFSAN)
 The Center for Devices and Radiological Health (CDRH)
 The Center for Veterinary Medicine (CVM)
 The National Center for Toxicological Research (NCTR)
 The Office of Regulatory Affairs (ORA)
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9. Sr.
No
Component Full Form Regulates
1. CBER Center For Biologicals Evaluation
And Research
Biological Products
2. CDRH Center For Devices And
Radiological Health
Safety and Effectiveness of New Medical Devices
Before they are Marketed
3. CDER Center For Drug Evaluation And
Research
Prescription medications and OTC
4. CSFAN Center For Food Safety And
Applied Nutrition
Food Supply is Safe, Sanitary, and Honestly
Labeled, and Cosmetic Products are Safe and
Properly Labeled.
5. CVM Center For Veterinary Medicine Assure that Animal Food Products are Safe.
6. NCTR National Center For Toxicological
Research
Human Toxicity
7. OCI Office Of Criminal investigation Provide leadership
8. ORA Office Of Regulatory Affairs Products Comply with Appropriate Public Health
Laws and Regulations.
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10. 1. Biologics
▪ Vaccines
▪ Blood products etc.
2. Cosmetics
▪ Safety
▪ Labeling etc.
3. Drugs
▪ Priscription
▪ OTC
▪ Generic etc. 6
PRODUCTS REGULATED BY FDA
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11. 4. Foods
▪ Dietary supplements
▪ Nutrition etc.
5. Medical Devices
▪ Contact lenses
▪ Hearing aids etc.
6. Radiation-Emitting Electronic Products
▪ Lasers
▪ Microwaves etc.
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12. 7. Veterinary Products
▪ pet foods
▪ veterinary drugs and devices etc.
8. Tobacco Products, including:
▪ cigarettes
▪ cigarette tobacco
▪ roll-your-own tobacco
▪ smokeless tobacco etc.
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13. WHAT FDA DOES NOT REGULATE
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I) ADVERTISING
II) ALCOHOL
III) CONSUMER PRODUCTS
IV) DRUGS OFABUSE
V) HEALTH INSURANCE
VI) MEATAND POULTRY
VII) PESTICIDES
VIII) RESTAURANTS AND GROCERY STORES
IX) WATER

14. FDA shares the responsibility for regulating these
products with other government agencies:
 Pesticides ( U.S. Department of Agriculture, and the
Environmental Protection Agency regulate these).
 Water (FDA regulates the labeling and safety of bottled
water, while the Environmental Protection Agency
develops national standards for drinking water from
municipal water supplies).
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15. LAWS ENFORCED BY FDA
 Federal Food, Drug and Cosmetic Act
 Food and Drug Administration Modernization Act
(FDAMA)
 Infant Formula Act of 1980
 Orphan Drug Act
 Drug Price Competition and Patent Term Restoration Act of
1984
 Medical Device Amendments of 1992
 Prescription Drug User Fee Act (PDUFA) 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
 Best Pharmaceuticals for Children Act
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16.  Medical Device User Fee and Modernization Act
(MDUFMA) of 2002
 Animal Drug User Fee Act of 2003 PDF
 Minor Use and Minor Species Animal Health Act of
2004
 Food Allergen Labeling and Consumer Protection Act
of 2004
 Federal Anti-Tampering Act
 Sanitary Food Transportation Act
 Mammography Quality Standards Act (MQSA)
 Bioterrorism Act of 2002
 Public Health Service Act
 Trademark Act of 1946
 Controlled Substances Import and Export Act
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17. FDA globalisation
• USFDA as identify the following countries from which most of food
and drug are improved.
• China
• India
• Europe
• Latin America
• Middle East
• North Africa
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18. USFDA IN INDIA
 In India FDA ensures that food and medical product exported
from India to the US are safe and effective.
 Engaging with Indian regulatory authorities to ensure the
timely exchange of information regarding clinical trials of drug
which are marketed in US.
 Increased FDA inspection frequency.
 Co-ordinating and collaborating on product quality and safety
issues with other Indian government agencies.
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19. FUNCTIONS
• Protecting the public health by assuring that food are safe ,
sanitary and properly labelled.
• Veterinary drugs and vaccines, biological product, medical
devices which are intended for human use are safe and effective.
• Protect the public from electronic product radiation.
• Regulating tobacco products.
• Assuring cosmetic products are safe.
• Provide the accurate science based information.
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20. Reference
• Dr.Ruchi Tiwari, Dr.Gaurav Tiwari “Intellectual property rights and
drug regulatory affairs”. Pg no (8.1-8.36)
• Dr.B S Kuchekar, Mr.A M Khadatare “FORENSIC PHARMACY” 7th
Edition August 2007 pg no(17.8-17.28)
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