| DCL currently serves over 200 SPL clients and has successfully converted over 2,000 labels. |
Advantages
The FDA already requires electronic submission in lieu of paper forms for prescription and OTC drugs, as well as for veterinary and biological drugs. In the future, SPL labels will also be required for medical devices. A comprehensive collection of available SPL information for prescription drugs can be accessed on DailyMed (via the National Library of Medicine website).
How DCL can help
DCL provides comprehensive SPL conversion services to handle all product types. We also support electronic Establishment Registration and NDC Labeler Code requests and submissions. Our extensive quality control processes ensure accuracy, and we maintain ongoing contact with the FDA to keep up with any changes that might affect our clients.
- SPL - Fact Sheet
XML Structured Product Labeling for the Pharmaceutical Industry (9/2009)
http://www.dclab.com/spl_conversion.asp - Structured Product Labeling (SPL) Frequently Asked Questions (12/2009)
http://www.dclab.com/spl.asp - Structured Product Labeling R4 (SPL) Frequently Asked Questions (12/2009)
http://www.dclab.com/spl_r4.asp
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DCL White Papers
- MEETING THE FDA'S EMERGING SPL REQUIREMENTS
Meeting the FDA's requirement for XML formatted data for pharmaceutical Structured Product Labeling (SPL) submissions fall into three main categories: service, hosted and enterprise. Which is best for you? (2/2009)
http://www.dclab.com/fda_spl_requirements.asp
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DCLnews Articles
- Life Science (12/2009)
http://www.dclab.com/main_lifescience.asp - Everyone's an Expert
Crowdsourcing is a little like yelling a question at a very large crowd of people. If the crowd is big enough, chances are someone in there is going to have the answer. And so it is with crowdsourcing, the phenomenon in which tasks or questions are outsourced to the masses in an open call. (11/2009)
http://www.dclab.com/crowdsourcinghistory.asp - Newest SPL Requirements For Life Sciences Industry Supported by Data Conversion Laboratory
Deb Lockwood's article is an excellent illustration of just how important it is to convert your documentation to the right format, and it also serves as a reminder of how much work and management effort goes into a do-it-yourself conversion. (11/2009)
http://www.dclab.com/spl_requirements.asp - Wyeth Pharmaceuticals & XML; Beyond compliance to smarter, faster, higher-quality document publishing: An interview with Bernie Coney
Learn how one division of Wyeth Pharmaceuticals moved to a regulatory compliance standard, and now shows greater consistency, efficiency, and higher-quality documents. (9/2008)
http://www.dclab.com/pharma_xml_interview.asp - NO MORE PDF: XML-BASED DRUG-LABELING BECOMING FDA REQUIREMENT
New "SPL" drug labeling standard brings many advantages, but could cause start-up pains for pharmaceutical companies. DCLnews reports (9/2005)
http://www.dclab.com/spl_standard_requirement.asp - XML-BASED SPL DRUG LABELING STANDARD MAKES FOR SAFER
MEDICATION
The Structured Product Labeling (SPL) initiative from the FDA promises greater safety and will help pharmaceutical companies better disseminate critical drug information. DCLnews reports. (3/2005)
http://www.dclab.com/spl_standard.asp
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