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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. This annex revises annex 6 on uniformity of dosage units general chapter that issued on June 16, 2014. This revision changes section II.B (2.2) of this annex to correctly state that the acceptance criteria are harmonized between the three pharmacopoeias.
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All written comments should be identified with this document's docket number: FDA-2009-D-0011.