TOBI 2017 Faculty Andrew Ittleman, JD, has published a valuable article on how the FDA should regulate human cells. This article, which appeared in The Regulatory Review, provides a brief history of the FDA’s involvement in the regulation of human cells, starting with the Wall Street Journal Op-ed, “The FDA Wants to Regulate Your Cells“, written by Scott Gottlieb in 2012. Gottlieb is now the Commissioner of the FDA. Ittleman analyzes Gottlieb’s political history regarding the regulation of human cells, as well as FDA’s, and delivers serious gems regarding his predictions for what regulations the FDA will roll out this fall, in addition to what they should.
See the full article here.