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Food and Drug Administration (FDA)

Overview

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices, including:

• Center for Biologics Evaluation and Research, which regulates products such as vaccines, blood, and gene therapy • Center for Devices and Radiological Health, which regulates medical devices ranging from thermometers to kidney dialysis machines, and electronic products that give off radiation, such as microwave ovens • Center for Drug Evaluation and Research, which regulates over-the-counter and prescription medications • Office of Regulatory Affairs, which conducts inspections and enforces FDA regulations • Office of the Commissioner, which provides leadership and direction to FDA’s product centers, research center, and Office of Regulatory Affairs.

Among other things, FDA is responsible for • Advancing the public health by helping to speed product innovations • Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health • FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

In the healthcare context, FDA regulates • human drugs • vaccines, blood products, and other biologics • medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers

Agency Guidance

The first comprehensive federal consumer protection law was the 1906 Food and Drugs Act, which prohibited misbranded and adulterated food and drugs in interstate commerce. Arguably the pinnacle of Progressive Era legislation, the act nevertheless had shortcomings—gaps in commodities it covered plus many products it left untouched—and many hazardous consumer items remained on the market legally.

The tipping point came in 1937, when an untested pharmaceutical killed scores of patients, including many children, as soon as it went on the market. The enactment of the 1938 Food, Drug, and Cosmetic Act tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government’s ability to enforce the law. This law, as amended, is still in force today.

From FDA website, http://www.fda.gov/AboutFDA/Transparency/Basics/.