Gottlieb On Gene Therapies: 'Very Seductive' To Think About Accelerated Approval Pathway

07 May 2018

• By Michael Cipriano

Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.

Genetic Medicine with dna isolated on white.3d rendering

As the US FDA plans to release guidance clarifying its approach for regulating gene therapies, agency Commissioner Scott Gottlieb provided some insight into the agency's thinking on the subject when he called it "very seductive" to think about the accelerated approval pathway for such therapies.

Speaking at the Reagan-Udall Foundation's annual meeting May 4, Gottlieb stressed that the most critical questions in the review of...