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Introduction to FDA's Regulation of Pharmaceuticals

23 February 2017

The U.S. Food and Drug Administration (FDA) regulates pharmaceutical products under a highly complex legal framework intended to ensure that companies market products that are safe and effective. The research and development, manufacturing, approval, labeling, marketing, import and export, and distribution of pharmaceuticals in the United States are regulated primarily under the Federal Food, Drug, and Cosmetic Act (FDCA).

The approval requirements under the FDCA and the implementing regulations issued by FDA reflect a careful balance of policy and science that encourages the development of new pharmaceuticals while also providing a pathway for low-cost generic products. Regardless of whether it is a brand-name or generic product, manufacturers must ensure that their products are manufactured in accordance with FDA's current Good Manufacturing Practice (cGMP) requirements, which are enforced through FDA inspections. Often, the regulatory framework governing pharmaceuticals must balance competing tensions, such as FDA's regulation of pharmaceutical advertising and promotion and a manufacturer's First Amendment rights.

This course provides an introduction to the regulation of pharmaceuticals by FDA. It reviews approval requirements for brand-name and generic products, advertising and promotion issues, and pharmaceutical manufacturing issues in a global environment. Join Susan Lee, Jim Johnson and Gary Veron, partners in the Pharmaceutical and Biotechnology practice group in the Washington, D.C. office of Hogan Lovells, for this discussion.

Learning Objectives:

I. Learn about key areas of the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations
II. Know the regulatory framework governing the approval of brand-name and generic pharmaceutical products
III. Understand compliance and enforcement risks associated with the manufacturing of pharmaceutical products in a global environment
IV. Grasp the basic tenets of pharmaceutical advertising and promotion
V. Discuss recent developments in FDA's regulation of pharmaceuticals

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