Archives for December 15, 2014

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Europe's response "disproportionate" says GVK Biosciences

By Gareth Macdonald

GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.

IPEC-Americas aims to make drug excipient users TUPP aware

By Gareth Macdonald

Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.