FDA Needs To Change How It Regulates Novel Technologies

By Scott Gottlieb (original source Forbes)

“I spoke before a meeting of the International Society for Stem Cell Research in Berkeley, Calif., this week, addressing the need for the Food and Drug Administration to adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy.

The thrust of my message was this: FDA needs to more closely focus is organizational structure and its regulatory programs on measures of risk, and move away from its structural legacy that oriented its review programs mostly around discrete clinical areas of medicine.”

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