Following receipt of the orphan drug designation request at OOPD, the review process is as follows: the request is assigned a designation request number, logged into OOPD database, and an acknowledgement letter is sent to the sponsor (or sponsor’s agent). The assigned OOPD reviewer completes the review of the request, which may require consultation with an FDA Center. The review is forwarded to the Director of the Orphan Drug Designation Program for a seconds level review and concurrence. Following the OOPD Office Director’s concurrence, a designation letter, a deficiency letter requesting additional information, or a denial letter is prepared for the OOPD Office Director’s signature and the letter is then issued to the sponsor.
