Drugs

Mutagenic Impurities Guideline Adopted

Members of the International Council for Harmonization Regulatory Assembly have approved the M7(R2) guideline, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, that emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose a negligible carcinogenic risk. The document outlines recommendations for the assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, considering the intended conditions of human use.

The guidance is intended to provide recommendations for new drug substances and new drug products during their clinical development and subsequent applications for marketing. It also applies to post-approval submissions of marketed products, and to new marketing applications for products with a drug substance that is present in a previously approved product, in both cases only where:

changes to the drug substance synthesis result in new impurities or increased acceptance criteria for existing impurities;
changes in the formulation, composition, or manufacturing process result in new degradation products or increased acceptance criteria for existing degradation products;
changes in indication or dosing regimen are made that significantly affect the acceptable cancer risk level.

The document contains an Introduction, Scope of Guideline, General Principles, Considerations for Marketing Products, Drug Substance and Drug Product Impurity Assessment, Hazard Assessment Elements, Risk Characterization, Control, Documentation, Notes, Glossary, References, and Appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome