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No 12-Year Exclusivity In US FDA's NDA-To-BLA Switch

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has published new draft guidance describing how it plans to take certain protein products that have been approved through Food, Drug and Cosmetic Act (FDCA) processes like the new drug application (NDA) pathway and move them over to the biologics license application (BLA) process1.

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