Orphandrug 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。
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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.