In mid-June, FDA announced the availability of a final guidance entitled, “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.” The guidance provides evaluation results from the ICH Q4B General Chapter harmonized text and is in the form of an annex to the core guidance on the Q4B process entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.”
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