Month: October 2020

nitrosamine-impurities

Nitrosamine Impurities: A Regulatory Perspective

In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine impurity had been detected in a pharmaceutical drug. The unexpected delivery of these impurities resulted in voluntary product recalls on a mass scale and led …

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Worldwide COVID-19 Vaccine Development – A Regulatory Perspective.

The race against time to find a vaccine for the new, deadly coronavirus is well underway. Currently, over 170 candidate vaccines are being followed by the World Health Organization in an attempt to find a viable vaccine in a short span of time. While the Governments and researchers across the world are sprinting to develop …

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