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July 2023

nitrosamine impurity risk assessment

What does the EMA update on nitrosamine impurities mean for you?

Discuss, Innovate /

Revised guidance released by the European Medicines Agency (EMA) on 7th July sparked excitement within the scientific community. By unveiling a new system to classify nitrosamines, EMA demonstrates that regulators are supporting industry in solving the complex problem of nitrosamine impurity assessment. The new approach will benefit industry, regulators and ultimately patients. What exactly are the […]

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The future of dermatological safety: FDA’s new approach to predicting dermal sensitisation

Innovate /

Traditional methods for evaluating the immunotoxic potential of pharmaceuticals typically involve animal testing, which is time-consuming, costly, and raises ethical concerns. In response to these challenges, regulatory agencies, including the Food and Drug Administration (FDA), are actively encouraging the development and acceptance of alternative methods. FDA’s new guidance on dermal sensitisation The FDA has recently

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