FDA Council assists businesses with U.S. FDA compliance. FDA Council is not affiliated with the U.S. FDA.
What We Do
FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. FDA Council can help modify your drug labeling to comply with FDA regulations. FDA Council provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.
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