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US FDA ends approvable and non-approvable letters for drugs

This article was originally published in Scrip

Executive Summary

The US FDA's drugs centre will do away with issuing "approvable" and "not approvable" letters in favour of "complete response" letters that describe specific deficiencies of an NDA or ANDA. While the FDA says the new rule will bring greater consistency and neutrality to its communications with sponsors, the change threatens to decrease the transparency surrounding a drug application's status to those outside the company and agency.

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