Let’s Learn about

Sahil Khatter

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 (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

FDA regulat

es

Cosmetics

Drugs

Foods

Medical

Devices

Radiation

emitting

electronic

products

Veterinary

products

Biologics

FDA Functions-

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

Provides centralized agency-wide program direction and management services to support effective administration and FDA's consumer protection efforts within its regulatory framework and to put available resources to the most efficient use. 

Office of the Commissioner

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.

Center For Drug Evaluation and Research

Center for Biologics evaluation and Research(CBER)

Center For Food Security and Applied Nutrition

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.

CDRH Controls over

CENTER FOR VETERINARY MEDICINERegulates food, food additives, and drugs that are given to animals(food animals, pets)

Primary focus –1.on medications that are used in food animals, and2. assurance that they don’t affect human food supply

Restricts the spread of bovine spongiform encephalopathy by doing inspections of feed manufacturers

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.

ORA mission is to enhance public health by implementing FDA regulations and minimizing the risks associated with the products

Office Of Regulatory Affairs

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. -

Office Of Criminal Investigation