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EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials

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EU regulators have released for public consultation a guideline under development by the International Conference on Harmonisation (ICH) intended to establish the best practices for controlling Read More...

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ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration

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The International Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic Read More...

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Final Guideline on Antibiotic Impurities Focuses on Manufacturing Processes

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The European Medicines Agency (EMA) has released final its final guideline on how to set specifications for impurities present in antibiotics not covered by other internationally-harmonized Read More...

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USP Releases Overhaul of Impurities Testing Standards

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The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products.The standards, Read More...

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EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials

ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration

Final Guideline on Antibiotic Impurities Focuses on Manufacturing Processes

USP Releases Overhaul of Impurities Testing Standards

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