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"In addition, some of our members have observed that some FDA reviewers seem to be applying the thresholds in the EMA guideline during their reviews, although FDA has not announced its intention to do so, and other FDA reviewers may be taking a different approach." AAM asked FDA to publish a more detailed guidance clarifying expectations for establishing thresholds for impurities to avoid changing expectations and inconsistent reviews

(2023) 11(5):e0125623

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