Believe it or not, it’s that time of year to start thinking about making the most out of your JP Morgan 2018 experience. Given what we know and have come to anticipate, each year investors and partners expect to see various (and promising) regulatory milestones achieved, and in the past three years all eyes have been on ORPHANS. Attaining an orphan drug designation or a rare pediatric disease designation, or having taken your orphan therapy through a pre-IND meeting gaining an understanding of agency expectations and a clear path forward makes a difference when interacting with potential partners.
With that said, and given the FDA’s current turn-around times for review and designation it’s time to start writing.
Depending on your application of interest, it can take the agency anywhere from 2-4 months to respond (potentially longer with the OOPD). On top of that, you have to take into consideration your own preparation and submission time.
For example, for an Orphan or a Rare Pediatric Designation the OOPD aims to respond to at least 75% of applications in 120 days. And we’ve seen them push right up to this timeline!
Below is a quick cheat sheet to help you start planning.
FDA Review & Response Time
If you want to be prepared, start NOW.
Need to know if you are ready for any of the above? Contact RareMoon to have a conversation. Or if you are looking to get this done and need assistance with preparing, finalizing or submitting any of these applications, we can support you.
For more information and an insight into EMA timelines, check out a similar post I wrote last year.
