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In the United States, all food, drugs, cosmetics, and medical devices, for both humans and animals, are regulated under the authority of the Food and Drug Administration (FDA). The Food and Drug Administration and all of its regulations were created by the government in response to the pressing need to address the safety of the public with respect to its foods and medicinals. The purpose of this review is to describe and explain the nature and extent of these regulations as they apply to drugs in the United States. This review discusses the FDA’s regulatory oversight and that of other agencies, the drug approval and development process, the mechanisms used to regulate manufacturing and marketing, as well as various violation and enforcement schema.

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The primary responsibility for the regulation and oversight of pharmaceuticals and the pharmaceutical industry lies with United States Food and Drug Administration (FDA). The FDA was created in 1931 and is one of several branches within the US Department of Health and Human Services (HHS). The FDA’s counterparts within HHS include agencies such as the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Healthcare Financing Administration (HCFA).

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The FDA is organized into a number of offices and centers headed by a commissioner who is appointed by the president with consent of the senate. It is a scientifically based law enforcement agency whose mission is to safeguard the public health and ensure honesty and fairness between health-regulated industries (i.e., pharmaceutical, device, biological, and the consumer).1 It licenses and inspects manufacturing facilities; tests products; evaluates claims and prescription drug advertising; monitors research; and creates regulations, guidelines, standards, and policies. It does all of this through its Office of Operations, which contains component offices and centers such as the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Orphan Products Development, the Office of Biotechnology, the Office of Regulatory Affairs, and the National Center for Toxicological Research. Each of these entities has a defined role, although sometimes their authorities overlap. For example, if a pharmaceutical company submits a drug that is contained and delivered to a patient during therapy by a device not comparable to any other, then the CDER and CDRH may need to coordinate that product’s approval. Although most prescription drugs are evaluated by the CDER, any other center or office may become involved with its review. One of the most significant resources to industry and consumers is the FDA’s web site www.fda.gov. Easily accessible and navigable, each center and office has its own HTML within the site.

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The FDA is not the only agency within the US government with a stake in pharmaceutical issues. The Federal Trade Commission (FTC) has authority over general business practices in general, ...

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