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Industry Urges FDA to Reduce Scrutiny of Low-Risk Importers

This article was originally published in The Gold Sheet

Executive Summary

The pharmaceutical industry generally supports the idea of FDA proposing a certified importer program for highly compliant manufacturers but urges caution in how risk levels for different importers would be assigned under FDA’s pending import regulations. They also say that low-risk importers should be subject to less scrutiny than high-risk ones.

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