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SPL for OTCs

This article was originally published in The Tan Sheet

Executive Summary

The Center for Drug Evaluation & Research will focus on structured product labeling (SPL) requirements for OTC drugs once it gets past the initial launch of SPL for Rx drugs in late October, CDER Office of Business Project Support Program Manager Lisa Stockbridge stated. Starting Oct. 31, manufacturers must submit label changes in electronic format using structured product labeling for all NDAs and ANDAs. Focus on SPL for OTCs is targeted for August 2006, she said during the Regulatory Affairs Professional Society annual meeting in Baltimore, Md., Oct. 17. Transition to SPL has been delayed several times since FDA's release of draft guidance on the topic in February 2004; the final guidance was issued in April. Implementing SPL places a "larger workload" on CDER, with the biggest burden on generic drugs due to a higher volume of labeling, Stockbridge said. The FDAer urged patience as the agency begins to adapt to the new system...

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