Viral vectors get the green light

WASHINGTON - The FDA's Vaccines and Related Biological Products Advisory Committee gave a green light to the continued use of viral vectors for delivery of gene therapies and approved the FDA's current methods of regulating related technologies.

Up to now, most gene therapy issues have been dealt with by the Recombinant Advisory Committee, but as products move into the clinic, the baton is passing to the FDA. The idea behind last week's meeting was to deal with some of the basic safety and efficacy issues prior to the first submission for product approval...