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ICH Guidance on Bacterial Endotoxins

07/19/2010

Federal Register Notice: FDA is making available a draft guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions; Annex 14: Bacterial Endotoxins Test General Chapter prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopeias (U.S., European, and Japanese) represented by the Pharmacopeial Discussion Group (PDG). To download this guidance, click here. To view this notice, click here.

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