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Gottlieb pointed to the hundreds of Investigational New Drug applications currently in place for cell and gene therapies, citing one study that suggests as many as 40 of these drugs could be approved over the next few years.....

”A lot of the complexity with gene therapy is in product-related issues, not the clinical issues. Whereas with normal drug review, I’d say 80% is the clinical portion and 20% is the CMC and product portion of the review,” he said, referring to the Chemistry, Manufacturing and Controls section of an application.

”I think with gene therapy and cell-based regenerative medicine it’s completely inverted. We’re having to think very differently about the regulatory issues with these.”
— Scott Gottlieb, Head of the FDA as quoted in post at BioPharma Dive

FDA guidelines should be very interesting.  They recognize the growth and potential in this area.   Read the whole post at BioPharmaDive, here.