Virginia Contract Research Organization Co., Ltd. (VCRO) has successfully prepared and submitted an orphan drug designation application for an oncology disease. US FDA granted the application without any question and comment in 50 calendar days. This accomplishment can be further extended to a fast track designation for the sponsor.
Congratulations! Orphan drug designation granted by the US FDA in 50 days, no question asked.
Virginia Contract Research Organization Co., Ltd. (VCRO) has successfully prepared and submitted an orphan drug designation application for an oncology disease. US FDA granted the application without any question and comment in 50 calendar days. This accomplishment can be further extended to a fast track designation for the sponsor.