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FDA Suggests Use of Biomarker Qualification Program as Possible Model for Approving Novel Excipients

This article was originally published in The Gold Sheet

Executive Summary

To encourage the development of novel excipients, FDA has suggested retooling its existing Biomarker Qualification Program from new drugs to new excipients. Instead of using this model solely to qualify the safety of new drugs, it also can be used to assess the safety of new excipients.

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