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EMA Draft Guidelines: Reproductive Safety and Predictive Biomarker Assays
The European Medicines Agency (EMA) has released two draft scientific guidelines for public consultation, covering reproductive safety assessment and predictive biomarker assay development throughout the medicinal product lifecycle. The first guideline addresses the assessment of fertility, pregnancy and breastfeeding risks, while the second provides recommendations for developing, validating and maintaining predictive biomarker assays, including companion diagnostics (CDx).

Sharan Murugan
2 hours ago3 min read
