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US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Executive Summary

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

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Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

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