USFDA Over View

Presented By…..
Mr. Tarif Hussian
M.Pharm. (SEM-I)
Dept. of Pharmaceutical Sciences
Guided By…..
DR. Arun Nanda
Professor of Pharmaceutics

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Contents
● Introduction
● History
● Organization of FDA
The Center for Biologics Evaluation and Research (CBER)
The Center for Devices and Radiological Health (CDRH)
The Center for Drug Evaluation and Research (CDER)
The Center for Food Safety and Applied Nutrition (CFSAN)
Center for Tobacco Products
The Center for Veterinary Medicine (CVM)
The National Center for Toxicological Research (NCTR)
● Conclusion
c

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INTRODUCTION
The Food and Drug Administration (1930) is a federal agency of
the United States Department of Health and Human Services, one of
the United States federal executive departments.
 Its headquarter located at White Oak, Maryland
The agency also has 223 field offices and13 laboratories located throughout the 50
states of USA.
Mission is to protecting consumers and promote public health .
FDA started opening office in foreign countries including China ,India, Costa Rica ,
Chile, Belgium and UK etc.

What does FDA regulate?
Foods, except for most meat and poultry products, which are regulated by the
U.S. Department of Agriculture.
Food additives
Infant formulas
Dietary supplements
Human drugs
Vaccines, blood products, and other biologics
Medical devices, from simple items like tongue depressors, to complex
technologies such as heart pacemakers.
Electronic products that give off radiation, such as microwave ovens and X-ray
equipment.
Cosmetics.
Feed, drugs, and devices used in pets, farm animals, and other animals.
Tobacco products

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FDA does not regulate
Advertising (except for prescription drugs, medical devices, and tobacco
products)
 Alcoholic beverages
Some consumer products, such as paint, child- resistant packages, baby toys,
and household appliances (except for those that give off radiation)
 Illegal drugs of abuse, such as heroin and marijuana.
 Health insurance
 Meat and poultry (except for game meats, such as venison, ostrich, and snake).
 Restaurants and grocery stores.
What doesn’t FDA regulate ?

1902 – Biologics Control Act
1906 – Pure Food and Drug Act
1944 – Public Health Service Act
1951 – Food, Drug, and Cosmetics Act Amendments
1962 – Food, Drug, and Cosmetics Act Amendments
1966 – Fair Packaging and Labeling Act
1976 – Medical Device Regulation Act
1987 – Prescription Drug Marketing Act
1988 – Anti–drug Abuse Act
1990 – Nutrition Labeling and Education Act
1992 – Prescription Drug User Fee Act
1994 – Dietary Supplement Health and Education Act
1997 – Food and Drug Modernization Act
2002 – Bioterrorism Act
2002 – Medical Device User Fee and Modernization Act (MDUFMA)
2003 – Animal Drug User Fee Act
2007 – Food and Drug Administration Amendments Act of 2007
Note:-The FDA also enforces other laws, notably Section 361 of the Public Health Service Act
and associated regulations, many of which are not directly related to food or drugs.
HISTORY

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ORGANIZATION OF FDA
● FDA Commissioner :- Dr. Stephen M. Hahn
● The Office of Regulatory Affairs (ORA):- which conducts inspections
and enforces FDA regulations.
● The Center for Biologics Evaluation and Research (CBER):- which regulates products
such as vaccines, blood, and gene therapy.
● The Center for Devices and Radiological Health (CDRH):- Which regulates medical
devices ranging from thermometers to kidney dialysis machines, and electronic products that
give off radiation, such as microwave ovens.
● The Center for Drug Evaluation and Research (CDER):-which regulates over-the-counter
and prescription medications.
● The Center for Food Safety and Applied Nutrition (CFSAN):- which regulates most foods
(except meat and poultry, which are regulated by the U.S. Department of Agriculture).
● Center for Tobacco Products:- which regulates cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco.
● The Center for Veterinary Medicine (CVM):- which regulates feed and drugs and devices
used in pets, farm animals, and other animals.
● The National Center for Toxicological Research (NCTR):- which supports FDA’s product
centers by providing innovative scientific technology, training, and technical expertise.

FDA ADVISORY COMMITTEE
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Advisory committees provide FDA with independent advice from outside
experts on issues related to human and veterinary drugs, vaccines and
other biological products, medical devices, and food.
In general, advisory committees include a chair, several members, plus
a consumer, industry, and sometimes a patient representative.
Additional experts with special knowledge may be added for individual
committee meetings as needed.
Although the committees provide advice to the agency, FDA makes the
final decisions.

The Center for Biologics Evaluation
and
Research (CBER)
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Biologic – a compound consisting or derived from, all or part of a living organism and used for
therapeutic or diagnostic purposes.
Examples of biological products include
● Vaccines blood and blood products ● Allergenic extracts
● Human cells and tissues used for transplantation (e.g. tendons, ligaments and bone)
● Gene therapies ● Cellular therapies
● Tests to screen potential blood donors for infectious agents such as HIV
Biologics License Applications (BLA) Process (CBER)
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for
introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is
regulated under 21 CFR 600 – 680. Form 356h specifies the requirements for a BLA. This
includes:
Applicant information
Product/Manufacturing information
Pre-clinical studies
Clinical studies
Labeling

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BLA Submission
After 60 days
If application
filable
Approved
Refused
If safe and
effective for its
labeled indication
● CBER controls the regulatory oversight of biologics INDs.
● BLA submission and Review-

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Center for Devices and Radiological Health
(CDRH)
● Premarket approval of all medical devices
● Medical device includes products from the simple toothbrush to complex
devices such as implantable brain pacemakers
● Also oversees the safety performance of non-medical devices which emit
certain types of electromagnetic radiation
● Regulates following category of radiation emitting electronic products:-
Radiation
• Ionizing X-ray:- e.g. Dental radiography, Industrial X-ray etc.
• Optical (Visible, UV, IR, Laser):-e.g. Surgical laser, Germicide lamp etc.
• RF, Microwave, magnetic: - e.g. MRI, Microwave oven etc.
• Acoustic (Ultrasonic):- e.g. Ultrasonography, Hearing aids etc.

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Functions of CDRH- Benefits Risks Regulate firms who
manufacture , repackage , relabel or Import medical devices sold in US .
● Getting safe and effective devices to market as quickly as possible
while ensuring that devices currently on the market remain safe and
effective .
● minimizes human exposure to radiation from medical, occupational and
consumer products.
● Providing accurate, science-based information about the products.
● Prescribes and enforces GMPs and performance standards for radiation-
emitting electronic products and medical devices
● To recall defective or noncompliant products.

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Class I (General Controls) –
• are low risk product
• e.g.- manual surgical instruments, canes, patient scales, adhesive bandages etc.
• Manufacturers have to register their facilities, list the products they manufacture, and
comply with GMPs.
• are exempt from 510(k) pre-market clearance application submission.
Class II (Special Controls) –
• entail a moderate degree of risk
• e.g. ECG monitors, x-ray machines and endoscopes
• Have to produce adequate assurance of safety and effectiveness
• require submission of a 510(k) premarket notification to FDA
Class III (Premarket Approval) –
• entail significant risk to the patient
• e.g. implantable cardiac pacemakers, angioplasty catheters
• manufacturer must submit to the FDA a Premarket approval application (PMA )
Classification of medical devices according to
M.D. Amendments; 1976:

Center for Drug Evaluation and Research
(CDER)
● Acts as consumer watchdog in America’s healthcare system.
● Oversees the research, development, manufacture and marketing of
drugs.
● Ensures safety and efficacy of available drugs.
● regulates :
● Prescription drugs
● Generic drugs
● OTC drugs
● Also ensures truth in advertising for prescription drugs.
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The Center for Food Safety and Applied Nutrition
(CFSAN) Regulates –
 food (except meat, poultry)
 Dietary supplements
 Bottled water and
 cosmetic products.
 The Food Safety Inspection Service (FSIS) in the U.S. Department of Agriculture
regulates meat and poultry products .
 Ensures that food products are safe, sanitary, wholesome and honestly labeled.
Dietary supplements
 The Dietary Supplement Health and Education Act (DSHEA) of 1994, created a new
regulatory framework for the safety and labeling of dietary supplements.
 A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to
supplement the diet.
 A Dietary ingredient must be one or any combination of the following substances:
● a vitamin ● a mineral ● herb or other botanical ● an amino acid ● a dietary substance for
use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues
from organs or glands) ● a concentrate, metabolite, constituent or extract.

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 Under the Federal Food, Drug, and Cosmetic Act (FFDCA) they do
not require FDA approval before they go on the market(except- colour
additives)
 FDA can only act after a cosmetic is on the market
 The agency has ways to monitor these products, which are-
• Voluntary Cosmetic Registration Program(VCRP)
• Inspections
• Surveys of products
• Cosmetic Ingredient Review (CIR) expert panel
 Also regulates labeling of cosmetics
Cosmetics Regulation

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 It Came into force after Family Smoking Prevention and Tobacco
Control Act,2009
 Authorizes FDA to-
• Require disclosure of tobacco product ingredients
• Create standards for tobacco products
• Restrict tobacco sales, distribution and marketing
• Require stronger health warning on packaging and in advertising
 Restricts the access and attractiveness of cigarettes to kids
 Bans the manufacture or sale of fruit or candy flavored cigarettes
 Convenes the Center’s Tobacco Products Scientific Advisory Committee for
use of menthol in cigarettes, dissolvable tobacco products
 Produces public information and education campaigns
Center For Tobacco Products

• Regulates food, food additives, and drugs that are given to animals(food animals, pets)
Primary focus –
1.on medications that are used in food animals.
2. assurance that they don’t affect human food supply
• Restricts the spread of bovine spongiform encephalopathy by doing inspections of
feed manufacturers
• New Animal Drug Application (NADA) submitted by sponsor
• Safety and efficacy of New Animal Drug Product should be assured before approval.
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Center for Veterinary Sciences
(CVS)

• Research arm of FDA
• The research at NCTR supports FDA’s goals:
1) To understand critical biological events in the expression of toxicity,.
2) To develop and characterize methods, and incorporate new technologies
to improve the assessment of human exposure, susceptibility, and risk.
3) To increase the understanding of the interaction between genetics,
metabolism, and nutrition.
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National Center for toxicological Research
(NCTR)

Calm mind brings
inner strength and
self-confidence, so
that's very
important for good
Health.
Dalai Lama
21

USFDA Over View

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