To obtain orphan drug designation, drugs must be for the treatment, prevention or diagnosis of a rare disease or condition.
孤儿药物审批流程需要该药物可以用于治疗、预防或者诊断罕见疾病。
It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation.
Simes说，“我们的目的是利用获得指定的孤儿药物权带来的益处，继续GVAX的研发。”
Orphan drug designation is available for drugs already approved for another disease or condition or for experimental drugs that have not been previously approved.
已经被批准用于其它疾病治疗的药物或者是尚处于试验阶段未被批准的药物都可以通过孤儿药物申报程序进行。
During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop.
研讨会期间，与会者将提出一个具体的孤儿药物按照FDA的孤儿药物审批过程进行研讨，并将其申请提交给FDA作为研讨会的总结。
During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop.
研讨会期间，与会者将提出一个具体的孤儿药物按照FDA的孤儿药物审批过程进行研讨，并将其申请提交给FDA作为研讨会的总结。
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