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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.

Latest From Bowman Cox

BARDA Expands US Domestic Production Of Single-Use Systems For Vaccine Manufacturing

FlexBiosys wins award; others to follow. New capacity may also benefit manufacture of monoclonal antibodies and cell and gene therapies.

Coronavirus COVID-19 Manufacturing

Communication Is Key In Adapting Production To Pandemic Component Supply Disruptions

US FDA is looking at risk-based approach for reporting changes in out-of-stock components such as plastic bioreactor bags, filters and tubing sets that are in short supply.

Manufacturing Post Market Regulation & Studies

US FDA Must Assess Business Impact Of Final Interstate Compounding MOU, Court Rules

Summary judgment puts 20-year-old effort to define ‘inordinate’ out-of-state drug compounding back on slow track.

Distribution Compliance

The Quality Lowdown: Corporate Culture And Site Complexity Can Pose Challenges

Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.

Manufacturing Quality

US FDA Board Formed To Manage Increasingly Complex Pharmaceutical Supply Chain Oversight

High-level board will bring together information from across FDA drug center and work to increase supply chain transparency, says CDER’s Jacqueline Corrigan-Curay. 

US FDA’s Machine Learning Analysis Suggests Where To Look For Manufacturing Site Quality Problems

XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.

Manufacturing Quality
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