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Structured Product Labeling: Moving Beyond PDF - A Discussion on Downstream Use

Explore the significance of structured data in SPL, focusing on post-submission data utilization, XML benefits over PDF, and NLM's role in biomedical information dissemination. Gain insights into SPL's impact and future applications.

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Structured Product Labeling: Moving Beyond PDF - A Discussion on Downstream Use

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  1. SPL/DailyMed JamboreeOctober 28, 2013Bethesda, MD

  2. SPL and DailyMed • Why not just use PDF? • Where is this going?

  3. Downstream use of SPL • Electronic submission of data established in 2005 • All marketed drugs and biologics must be submitted to FDA for posting on DailyMed • NLM originally asked to provide download access to the files. • Today’s meeting to focus on what happens to the data after it is submitted to FDA

  4. Why the big deal? • Authoritative • Freely available • Structured • XML text (plus images)

  5. Structured data - front of an envelope

  6. PDF drug labels also have structure… • Why not just use PDF? • Adobe PDF format designed for viewing and printing • Not designed for data extraction and re-use • XML: parseable, digestable, process-able by computers • Can use, re-use, re-arrange, sort, count, search and manipulate XML text data

  7. What does the NLM have to do with all this? • Largest repository of biomedical information in the world • RxNorm also from NLM • Researchers in biomedical text processing and information retrieval • Kin Wah Fung, Olivier Bodenrieder, and many others

  8. How today will work • Speakers will introduce themselves and their work • Please hold questions till the end • People online can send questions to Chris Hui: huic@mail.nlm.nih.govPlease identify who the question is for, if possible. • Two separate question panels; industry/non-government and government

  9. Where is this going?

  10. Thank you John Kilbourne MD kilbourj@mail.nlm.nih.gov

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