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Bowman Cox
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Latest From Bowman Cox
Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes
Draft recommendation offers path to ICH Q12 regulatory relief.
Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges
Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?
European Enforcement Activity Picks Up After Medicines Agency's Relocation
With the European Medicines Agency's Amsterdam move completed and the US/EU inspections MRA guillotine stayed, lull in EU drug GMP noncompliance notices has ended.
The Quality Lowdown: Spanish Falsification, Czech Mold And Dutch Contamination Cited After EU Lull Ends
Barcelona’s Union Quimico, Czech Republic’s Vakos and The Netherlands’ Pharma Essentials among those cited as the EMA ramps up in Amsterdam.
US FDA's Marks: Gene Therapy Success Could Hinge On Regulatory Convergence
Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.