Despite having an extra year before they must start submitting IND applications electronically to the FDA, companies should convert their IND process before NDAs and BLAs, in order to gain experience with smaller and less time-critical submissions.
Despite having an extra year before they must start submitting IND applications electronically to the FDA, companies should convert their IND process before NDAs and BLAs, in order to gain experience with smaller and less time-critical submissions.