Food and Drug Administration: Role in Drug Regulation

Authored by: Mei-Ling Chen

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:


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The Department of Health and Human Services (HHS) is the principal agency of the U.S. government for protecting the health of all Americans and providing essential human services. It is comprised of the Office of the Secretary and 11 Operating Divisions which include the Food and Drug Administration (FDA) (1). Although the FDA’s budget and staff are comparatively small (FY2010, $3.2 billions, 12,000 employees), this agency has broad authorities, responsibilities, and impact (2). The FDA protects the public health by: a) assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, b) ensuring the safety of foods, cosmetics, and radiation-emitting products, and c) regulating the manufacture, marketing, and distribution of tobacco products. The FDA is also responsible for advancing the public health by: a) helping to speed innovations that make medicines and foods more effective, safer, and more affordable; b) providing the public with the accurate, science-based information they need to use medicines and foods; c) reducing tobacco use to improve health; and d) addressing the nation’s counterterrorism capability and ensuring the security of the supply of foods and medical products.

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