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.
The Office of the Commissioner (OC)
The Center for Drug Evaluation and Research (CDER)
The Center for Biologics Evaluation and Research
The Center for Food Safety and Applied Nutrition
The Center for Devices and Radiological Health
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)
Drugs Foods Medical
Landmarks In Regulations
Food and Drug
Control Act 1970
User Fee Act
Acts as consumer watchdog in America’s healthcare
Oversees the research, development, manufacture and
marketing of drugs.
Ensures safety and efficacy of available drugs.
Also ensures truth in advertising for prescription drugs.
Industrial X-ray etc.
e.g. Surgical laser,
Germicide lamp etc.
Microwave oven etc.
Hearing aids etc.
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
Restricts the spread of bovine spongiform
encephalopathy by doing inspections of feed
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
ORA mission is to enhance
public health by implementing
FDA regulations and
minimizing the risks
associated with the products
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