Thank you for your update. But, how is this process different from requesting a Pre-IND meeting, which anyone an ask for? As far as anyone partnering with academia or anyone they want to partner with, that too has always been a choice.
You're right on - partnering with academia, CROs/consultants is not new. The main difference we're seeing here is that this pilot allows selected sponsors to submit pieces of an IND for FDA review on a rolling basis before the full IND is filed.
A normal pre-IND meeting is mainly for getting FDA advice on your plans and questions. This pilot is meant to let the FDA review actual completed sections early and catch potential problems sooner.
Thank you for your update. But, how is this process different from requesting a Pre-IND meeting, which anyone an ask for? As far as anyone partnering with academia or anyone they want to partner with, that too has always been a choice.
You're right on - partnering with academia, CROs/consultants is not new. The main difference we're seeing here is that this pilot allows selected sponsors to submit pieces of an IND for FDA review on a rolling basis before the full IND is filed.
A normal pre-IND meeting is mainly for getting FDA advice on your plans and questions. This pilot is meant to let the FDA review actual completed sections early and catch potential problems sooner.