There are nearly 30 million Americans that suffer from at least one of the more than 7000 rare diseases identified to date. Therapies for treating, preventing, or diagnosing rare diseases have been limited due to various reasons. Incentives are provided to sponsors in an effort to promote the development of therapies for rare diseases and to encourage the availability of therapeutically superior drugs or biologics. This paper will discuss the mission of the Office of Orphan Products Development within the Food and Drug Administration (FDA), the specific programs within the office and the relation to incentives provided, achievements of the programs, and continued challenges in rare disease product development.

中文翻译：

---

FDA的孤儿产品开发办公室：提供激励措施以促进罕见病产品的开发。

迄今为止，有近3000万美国人患有至少7,000多种罕见疾病中的一种。由于各种原因，已经限制了用于治疗，预防或诊断罕见疾病的疗法。为鼓励发起人提供奖励措施，以促进稀有疾病治疗方法的发展，并鼓励提供治疗上更优越的药物或生物制剂。本文将讨论食品和药物管理局（FDA）孤儿产品开发办公室的任务，办公室内的特定计划以及与提供的激励措施，计划的成就以及稀有疾病产品开发中的持续挑战之间的关系。