Regulatory & Safety

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

Consultant Anders Fuglsang: "Which pharma company would ever subcontract a partner without a QMS?" (iStock/Duncan_Andison)

The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

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US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

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EMA proposal concerns: “Public health trumps commercial confidentiality”

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US FDA warns liquid drug firms to test for Burkholderia cepacia

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EMA committee says AB Science’s Masitinib should not be approved in light of GCP failings

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US triples indications for Kalydeco without needing new clinical data

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France's ANSM raises GMP concerns at Brazilian aseptic plant

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AB Science suspends French masitinib trials after ANSM finds deviations

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Trump needs to back bioscience to boost US drug making say experts

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Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns

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