
FDA to Eliminate Backlog of Orphan Drug Designation Requests
The agency announced a plan to eliminate its existing orphan designation request backlog.
On June 29, 2017, FDA
A new FDA Orphan Products Council will address scientific and regulatory issues to ensure a consistent approach to the review of orphan drug requests. The agency will create a Backlog SWAT team that will focus solely on backlog applications, starting with the oldest requests. A Designation Review Template will be used to make the reviews more efficient. The program will collaborate with FDA’s medical product centers to conduct joint reviews, particularly with the Office of Pediatric Therapeutics to review rare pediatric disease designation requests. FDA will also revise grant monitoring processes and modernize reporting requirements. A new “Tracking Dashboard” will be created “to monitor and facilitate efforts to meet the new designation goals and FDA will report on overall workload and progress more regularly.”
The Orphan Drug Act created the
In 2016, the agency received 568 new orphan designation requests, which FDA says reflects scientific advances in the industry. “These scientific advances and new opportunities also create additional opportunities for FDA, as well as new challenges. The agency needs to make sure it is able to respond to these requests in a timely fashion, and efficiently grant new designations where it is supported by the underlying data,” FDA stated in the new plan.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.