The US Food and Drug Administration has drawn up new guidelines, including ones that touch on human cell- or tissue-based treatments like gene therapies and that could speed their review, the New York Times reports.
"These concepts are no longer the stuff of science fiction," FDA Commissioner Scott Gottlieb says in a statement, "but rather, real-life science where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; where new genes can be introduced into the body to combat disease; and where adult stem cells can generate replacements for cells that are lost to injury or illness."
In a press release, FDA says certain gene and cell therapies could now qualify for expedited review. Gizmodo notes that this is moving to fulfill a call by the 21st Century Cures Act to "simply and streamline" the regulation of regenerative medicine.
Michael Werner, co-founder of the Alliance for Regenerative Medicine, tells the Times that these new guidelines would enable more gene therapies to come to market. To date, FDA has approved two gene therapies and an agency advisory panel has recommended the approval of a third.
However, Michael Carome, director of Public Citizen's health research group, says at the Times that the nascent field needs more oversight as new products could be rushed to market.