Gottlieb: FDA Will Clear Backlog of Orphan Drug Requests Within 90 Days
The FDA will clear its backlog of orphan drug designation requests in the next 90 days, Commissioner Scott Gottlieb told Senate appropriators.The agency plans to assign a team dedicated to assessing the approximately 200 applications currently pending.
Once those applications are cleared, the FDA will implement a more streamlined orphan designation process that ensures every request receives a response within three months.
Gottlieb was on Capitol Hill June 20 to discuss the budget proposed for the FDA’s next fiscal year, testifying before the Senate appropriations subcommittee that oversees the agency’s funding. — Gayle S. Putrich