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FDA Raises Bar for Comparability Studies after Approval

This article was originally published in The Gold Sheet

Executive Summary

FDA sets a higher bar for approving comparability studies for biotech drugs once they have been approved for marketing than for the preapproval stage, but the regulatory expectations are clearer, said an agency official. Representatives of the biopharmaceutical industry also advised manufacturers to take a risk-based approach to assess comparability and outlined some methods that can be used to ensure that modifications do not affect drug safety and effectiveness.

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