F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics
The Food and Drug Administration (FDA) issued new guidelines to introduce gene therapy treatments earlier than expected, but also wants to crack down on rogue clinics offering dangerous or unproven versions of those treatments.
"This is an incredibly significant development for the gene therapy, regenerative medicine sector," said Partner Michael J. Werner. "This should really open the door to a lot more gene therapies coming on the market quickly," said Mr. Warner.