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FDA Approves Real-Time Release NDAs As Agency, Early Adopters Promote PAT

This article was originally published in The Gold Sheet

Executive Summary

Real-time release has arrived with FDA approval of two NDAs that rely on process analytical technology instead of end-product testing for release to market. Merck shares its experience with PAT-based real-time release at IFPAC meeting, while FDA officials express disappointment that pharmaceutical industry has not embraced PAT more broadly. Research funding, agenda explored. Business case made. Sterility concerns raised. Legacy opportunities explored

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