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FDA will soon slash supplement filing requirements

This article was originally published in The Gold Sheet

Executive Summary

A sharp reduction in supplement filing requirements should result from a guidance FDA is preparing to issue in the next few months, Office of Pharmaceutical Science Director Helen Winkle told the PDA/FDA meeting in Washington on Sept. 24. The guidance "will make a big difference," Winkle said. "I couldn't believe how long the list was - about 50 different supplements that we will no longer be asking for." One caveat: There will be exceptions for "extra-complex" drug products
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