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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.
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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.

Manufacturing Quality

PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes

Draft recommendation offers path to ICH Q12 regulatory relief.

Manufacturing Quality

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?

Drug Review Manufacturing

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.

Compliance Manufacturing

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.

Enforcement Manufacturing

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.

Regenerative Medicine Manufacturing
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