Reply To: Shipping clinical supply under quarantine from China to the US

Reply To: Shipping clinical supply under quarantine from China to the US

Correct me if I’m wrong, but the shipping on Q part is a business decision. If the CMO in China is OK with it, and your QA is OK with it, I think it’s allowable.

I don’t think realistically Customs or FDA cares (or has a mechanism to check) if it’s released or not.

Sounds like you have the IND # so you can enter that on the FDA letter and mark the end use as for clinical trials.

Let us know how this worked out!