ICH Consults On Guideline To Improve Bioanalytical Data Consistency
The finalization of a new international guideline that proposes a harmonized approach on bioanalytical method validation is expected to reduce the need for additional validation experiments and support streamlined global drug development.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.