Advertisement

FDA is advancing the goals of the Orphan Drug Act

Share This Page
FDA Commissioner Scott Gottlieb notes that 3 months ago he committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with the agency, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them.

FDA Commissioner Scott Gottlieb notes that 3 months ago he committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with the agency, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. He reports that, "owing to the dedicated efforts of the orphan drug designation team who oversee the Orphan Drug Designation Program, the first of these goals has been fully achieved. Reviews of all orphan drug designation requests older than 120 days were completed on August 28." Gottlieb also notes the agency is "putting in place new policies to improve the efficiency of our review process to ensure that we meet our new 90-day mandate to prevent new backlogs." FDA will reorganize its review staff to improve workload efficiencies and to better leverage the expertise across the agency's medical product centers. "We'll also use lean management principles to design a new process map that’s based on an assessment of sources of delay or redundancy and metrics for measuring success," Gottlieb adds. "This new workflow will outline a more efficient process that eliminates redundancies and delays that don’t add value."

Ad Position: 
Bottom Center Aligned
https://blogs.fda.gov/fdavoice/index.php/2017/09/fda-is-advancing-the-goals-of-the-orphan-drug-act/

Advertisement

Related Content

block-views-related-content-block