Regulatory Authorities and the Laws

Regulatory affairs exists only because the federal government has elected to regulate the pharmaceutical and biotechnology industries. The role of the FDA and its regulatory authority is defined by the laws legislated by Congress. Therefore, in order to understand the basics of regulatory affairs, it is necessary to understand how the FDA is established under the law, how it interprets and applies the laws it is responsible for administering, and some of the key legislation that gives the FDA its authority. This section of the chapter will also provide an introduction to the efforts to establish global harmonization of some regulatory requirements, with the intent of reducing and/or eliminating some of the testing required to bring new products to market. FDA has been a leader in this global harmonization effort.

This introduction to the regulatory authorities and the laws includes a brief overview of the organizational structure of

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable;

and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Fig. 7.1. FDA's Mission Statement the FDA to better understand how it interacts with the pharmaceutical industry and clinical investigators. It also includes the major laws that grant, and so limit, the regulatory authority of the agency. It further explains how FDA interprets the laws legislated by Congress into federal regulations and guidance and the multiple means that the FDA uses to communicate to the regulated industry and the nation's public. Finally, the role of other federal agencies that interact with the pharmaceutical and biotechnology industries, whether in a regulatory capacity or not, is described.

The mission statement of the FDA is found in Fig. 7.1. This mission statement reflects the current mission of the agency, which has evolved since its inception. At the time the FDA was first established in 1906, the role of the agency was limited to the protection of the public health. As public demands and therefore legislative demands have increased on the FDA, their mission has expanded.

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