Scientific Publications by FDA Staff

Adv Exp Med Biol 2015;871:1-29

United States Food and Drug Administration regulation of gene and cell therapies.

Bailey AM, Arcidiacono J, Benton KA, Taraporewala Z, Winitsky S

The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.