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Data Conversion Laboratory Structuring Pharmaceutical Data

机译:数据转换实验室构建药物数据

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摘要

New York-based Data Conversion Laboratory (DCL) has been converting documents electronically for more than 30 years. So when Health Science Funding, LLC, a small pharmaceutical company, approached DCL with a problem in getting its product information registered with the U.S. Food and Drug Administration (FDA) for a drug called Pras-tera, DCL's team knew how to expedite the process. At issue is Structured Product Labeling (SPL), a standard that the FDA has required for all human prescription products since 2005 and has since required for veterinary products, biologic products, nonprescription products, and medical devices.
机译:位于纽约的数据转换实验室(DCL)从事电子文档转换已有30多年了。因此,当小型制药公司Health Science Funding,LLC向DCL提出问题时,其产品信息已在美国食品和药物管理局(FDA)注册了名为Pras-tera的药物,DCL的团队知道如何加快这一过程。有争议的是结构化产品标签(SPL),这是FDA自2005年以来对所有人类处方药都必需的标准,并且自此以后对兽药,生物制品,非处方药和医疗设备也都要求该标准。

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