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FDA's New Accelerated Approval Draft Guidance - Pharmaceutical Executive

Retrieved on: 2025-03-11 18:13:35

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Summary

The article discusses the FDA's draft guidance on accelerated approval for biopharmaceuticals, focusing on expediting life-saving treatments. Experts like Cicchini and Gorman highlight the importance of understanding critical quality attributes and strategic planning to succeed in this pathway.

Article found on: www.pharmexec.com

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