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Usfda
1.
2. The Food and Drug Administration (FDA
or USFDA) is an agency of the United
States Department of Health and Human
Services and is responsible for regulating
and supervising the safety of foods, dietary
supplements, drugs, vaccines, biological
medical products, blood products, medical
devices, radiation-emitting devices,
veterinary products, and cosmetics.
3. The Office of the Commissioner (OC)
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)
The Office of Criminal Investigations (OCI)
FDA Organizations
5. Landmarks In Regulations
Food and Drug
Act 1906
Federal Food,
Drug and
Cosmetic Act
1938
Durham-
Humphrey
Amendments
1951
Hatch-Waxman Act
1984
Comprehensive
Drug Abuse
Prevention and
Control Act 1970
Prescription Drug
User Fee Act
1992
Drug Safety
Board 2005
Kefauver-Harris
Drug
Amendments
1962
Hatch-Waxman
Act 1984
6.
7. 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.
11. 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.
12. 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,
and
2. assurance that they don’t affect human food
supply
Restricts the spread of bovine spongiform
encephalopathy by doing inspections of feed
manufacturers
13. National Center
for toxicological
Research(NCTR)
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, and
3) to increase the understanding of the
interaction between genetics, metabolism, and
nutrition.
14. ORA mission is to enhance
public health by implementing
FDA regulations and
minimizing the risks
associated with the products
Office Of
Regulatory
Affairs
15. FDA’s Office of Criminal Investigations (OCI) is an integral part
of FDA’s mission to protect the public’s health. Top-flight special
agents –who have investigative authority similar to other federal
law enforcement agencies – give the FDA unique fact-finding
tools and provide for strong, industry-wide deterrence. Their
work is different from, but enhances, the regulatory inspectors
and investigators that make up the bulk of FDA’s field
operations. -
