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Structured Product Labeling guide

Executive Summary

The Structured Product Labeling Implementation Guide for FDA Content of Labeling Submissions Version 2a/Revision 1 has been released by the agency. The document is an interim implementation guide for the "SPL Release 2a" schema used by FDA for validating SPL submissions. The agency's "DailyMed" electronic labeling system will be implemented in November using the machine-readable structured product labeling format (1"The Pink Sheet" Oct. 3, 2005, p. 12)...
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