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IPEC Wants FDA To Clear Up Elemental Impurity Confusion

 
• By Joanne S. Eglovitch

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.

Periodic table of elements vector A4 size - Vector

The US FDA is mulling a proposal from the International Pharmaceutical Excipients Council-Americas (IPEC-Americas) for the agency to issue supplemental guidance clarifying the elemental impurity information that regulators can – and cannot – ask for when reviewing generic drug applications.

The group claims that FDA is asking for information that is not necessarily requested in the International Council on Harmonization’s...

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