FDA Asks for Comments on Joint U.S.-EU-Japan Guidance on Drug Impurity Limits

The Food and Drug Administration is asking for comments by Dec. 23 on a new draft guidance on elemental impurities in pharmaceutical products. The draft guidelines (here), agreed to by the joint U.S.-European Union-Japan International Conference on Harmonization, would set safety limits for specific elements, and emphasizes control of supply chains and risk assessments, FDA said. The joint standard would set consistent expectations for test requirements and regulatory filings among the three ICH countries, said FDA.