RE: Delay23 Feb 2026 17:38
All - just had a response from USA :
Good morning,
OOPD cannot provide status updates on submissions under review by the Agency. Please note that staffing changes at the beginning of 2025 have impacted our ability to maintain our internal policy for 90-day reviews. We ask for your patience as our office continues to review applications as fast as is accurately possible.
Please note that inquiries should include your ODD number, company codes are not relevant to orphan drug designation.
Kind regards,
Corey
Corey Burns, MPH
Project Management Officer
Office of Orphan Products Development
U.S. Food and Drug Administration
(240) 402-4036
orphan@fda.hhs.gov