Regulatory & Safety

Low budgets drive consolidation trend, say serialisation experts


According to industry delegates, smaller contract services firms struggling to meet track & trace implementation costs will look to consolidate with competitors in light of impending serialisation deadlines.    


Merck KGaA’s varied track & trace approach: 'We cannot rely on a singular security feature'


US FDA approves Amgen and Allergan's Avastin biosimilar


Biocon says Malaysia insulin plant passed HPRA inspection


No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe


German inspectors find problems at Dr Reddy's' Duvvada plant


When is a commercially available chemical not "commercially available"? ICH issues new Q11 Q&A

Celltrion's facilities in Incheon, South Korea were inspected by the US FDA in may and June

Celltrion confident in quality of biosimilar supply despite US FDA 483

Cadila facility in Moraiya (source Cadila)

Cadila says Moraiya drug plant has passed US FDA inspection


Hired while you were on holiday: pharma appointments

More Regulatory & Safety