Marks: Accelerated Approval Risks Worth It To Bring Patients Treatments Sooner

FDA biologics center director Peter Marks said the record of the accelerated approval pathway has been a positive one for patients, arguing in remarks Tuesday (May 7) the benefits of the pathway, like allowing treatments like gene therapies to reach patients more quickly, are worth occasionally needing to pull a drug off the market when confirmatory trials fail. Marks said the “north star” of the accelerated approval pathway should be using science to help patients. Speaking at the Reagan-Udall Foundation's...