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US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers

Executive Summary

Excipient suppliers complain about agency requests for elemental impurities data that go beyond ICH and USP requirements and delay approvals.

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IPEC Wants FDA To Clear Up Elemental Impurity Confusion

IPEC-Americas has proposed that FDA issue supplemental question-and-answer guidance to clear up confusion on what elemental impurity information FDA reviewers can ask of manufacturers and their excipient suppliers in connection with pending applications. The group said that generic manufacturers, primarily in India, “continue to have a significant number of questions and misunderstandings” of what elemental impurity information they are supposed to report to FDA.

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