The FDA Data Standards Council’s SPL web page http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm was updated on September 30, 2012, and October 1, 2012, to include the updated/new content described below:
- – Reorganization of SPL web page
- – Grouping of like documents (e.g. regulatory guidance documents) together
- – Removal of link to downloadable terminology files – Replaced with new webpage section: SPL Terminology Files for Validation
- – SPL Implementation Guide/Validation Procedures document updated
- – SPL stylesheet updated
- – SPL schema updated
- – New terminology: New document types, business operations, and a business operation qualifier
- – Resources section: Links to web pages with Comprehensive NDC SPL Data Elements File (NSDE) and SPL Software and Conversion Vendors web page
- – SPL Xforms web page: Removal of information about older SPL Xforms. Updated to include GDUFA Self-ID SPL templates
- – SPL terminology files for validation (new section) : active ingredient-active moiety/basis of strength, links to Cosmetic Product Category Codes and Device Product Classification web pages
- – GDUFA Self-ID SPL instructions documents.