• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail
-

Search Publications



Fields



Centers











Starting Date


Ending Date


Order by

Entry Details

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

Abstract

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.


Category: Journal Article
PubMed ID: #26374210 DOI: 10.1007/978-3-319-18618-4_1
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2016-02-19
Feedback
-
-