If you have submitted an orphan drug designation request (ODD) in the last 6 to 12 months, you have likely felt the wait. We have too, with some reviews moving faster than others. The Office of Orphan Products Development carries a heavy workload, and a good portion of what shapes review time sits outside their control. That raises a question worth asking: what can we control?
Our answer is the quality of the document we put in front of them.
RareMoon has worked with this office for more than 10 consecutive years, and I have been at it for 13. We have an excellent line of communication with the team, and we understand their volume, their expectations, and what a reviewable document looks like. When a reviewer can follow your argument with ease, the review moves efficiently, and that keeps the line moving for every sponsor waiting behind you. When a submission is difficult to follow, every reviewer pays for it in time, and the delay carries forward to the next sponsor in the queue.
We see this from the other side regularly. Clients bring us drafts to review before submission, and a growing number of them were written with heavy help from large language model tools. These drafts tend to miss the mark. The regulatory reasoning needs depth, the citations need verification, and the argument needs to meet the standard the office applies. A designation rests on experienced human judgment.
In my experience, a well-developed ODD is a pleasure to review, a pleasure to finalize and submit, and a pleasure to see come back with a swift granted letter.
Our recommendation is simple. Give the office documents that make their work easier, and your timeline benefits along with theirs.
If you would like to help them help you, reach out. We will draft your ODD from the beginning or take the one you have written and ready it for submission.
Contact the RareMoon team to discuss.