Pressroom

Fresh Meadows, NY – August 4, 2009: Data Conversion Laboratory, Inc. (DCL), providing conversion services and software to publishers, information aggregators, industry, government, libraries and documentation developers, continues to be in the forefront supporting the life sciences community in complying with the FDA’s SPL (Structured Product Labeling) initiative.

SPL is an XML standard used by the FDA community to facilitate communicating drug labeling data reliably among various medical groups. Since 2005, the FDA CDER division has mandated that all human prescription drugs be provided in SPL. Beginning in June, 2009 the FDA has required SPL filings for biologics, veterinary medicines and over-the-counter (OTC) products. Medical devices are expected to require SPL filing in 2010. Additionally, as a result of the Food and Drug Administration Amendments Act of 2007 mandating electronic submissions, SPL is now required for establishment registration, NDC labeler code requests and drug listing regulatory requirements.

As one of the world's leading providers of data conversion services, DCL has been well-positioned to understand the structure and usage of this new standard, and to assist affected organizations in implementing and utilizing SPL in a timely and efficient manner.  DCL supports the full range of SPL filings, is up to date on all technical requirements and has implemented sophisticated multi-level quality assurance checks to validate SPL files prior to submission. To date, DCL has successfully completed more than 2,000 filings.

Mark Gross, DCL president, expanded on DCL’s involvement with these regulations: “As a long-time member of the SPL Working Group helping to establish these standards, we were very comfortable with SPL from the beginning. As standards continue to evolve, our 28 years of industry experience and our ongoing interaction with the group enable us to provide rapid turnaround in support of our clients’ labeling conversions with guaranteed conformance to FDA and EMEA standards.”

Mark Gross, DCL President and CEO, responded: “After 28 years in the data conversion business we have worked with almost every type and condition of text. We appreciate the trust that The University of Chicago has placed in us, and we look forward to continuing to work with these interesting and important collections.”