CDRH’s Shuren Touts Improvements in FDA Process (HealthPointCapital)
Copy of Dr Shuren’s slides –> Dr Shuren – Memphis 11June12
In comments delivered in Memphis this week, CDRH Director Jeff Shuren announced that efforts to improve efficiency and speed up the regulatory process are paying off. Dr. Shuren said that decision times are decreasing and the FDA is engaging in less back-and-forth with devicemakers, and that progress will only continue with the support from the newly-authorized MDUFA III. “The good news is we’re seeing the canary in the coal mine is actually singing these days,” Shuren said of the CDRH.
In March, the CDRH announced new guidance for PMA applications as well as de novo applications (de novo devices are novel but lower-risk). Shuren said these initiatives were just the beginning of the CDRH’s work to improve the regulatory process and address devicemaker concerns about an unpredictable process. He promised that the device pathways would continue to improve, particularly given the recent re-authorization of user fee legislation. User fees will add about $600 million to the device division’s budget over the next five years, roughly doubling from the levels stipulated in MDUFA II. The additional funds will be used, in part, to hire more scientists to aid in the review process and speed up approval times.