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.”


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


EMA proposal concerns: “Public health trumps commercial confidentiality”


US FDA warns liquid drug firms to test for Burkholderia cepacia


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

Image: iStock/Kagenmi

US triples indications for Kalydeco without needing new clinical data

Image: iStock/alexis84

France's ANSM raises GMP concerns at Brazilian aseptic plant


AB Science suspends French masitinib trials after ANSM finds deviations


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

Image: iStock/artJazz

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

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