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CDER will index electronic labeling

Executive Summary

A recent FDA draft guidance says that CDER, rather than industry, will insert the machine readable tags known as "indexing" in Structured Product Labeling for drugs. FDA says consistent indexing from one source is needed so users can automatically search and sort product information more comprehensively. Elements that will be indexed include indication, limitations of and conditions for use and pharmacologic class. FDA will begin phased implementation by indexing products' pharmacologic classes, with other elements to follow...

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