US FDA’s 30-Day Extension For Nitrosamine Assessments Short Of Industry Recommendation
Revision to FDA's September 2020 guidance on assessing nitrosamine impurity risks associated with all chemically synthesized APIs and all approved drug products that contain those APIs doesn’t satisfy industry stakeholders.
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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.
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