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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

Hurricane Maria Tests Pharma Business Continuity Plans

Puerto Rico's slow recovery from Hurricane Maria provides insight into what happens when disaster strikes a node of the global pharmaceutical manufacturing network. Initial efforts to ward off US drug shortages focus on generic injectables that can't support expensive business continuity plans – but even critical prescription brands could be threatened if the US territory's power grid remains off line too long.

Manufacturing Scrip 100

Lawsuit, Warning Letter Mark Return Of B. Cepacia As GMP Issue

Lawsuit over infant's death and warning letter over recurring contamination underscore the importance of screening for Burkholderia cepacia and when found, removing the microorganism from pharmaceutical manufacturing processes.

Quality Compliance

FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes

Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.

Approvals FDA

ICH Seeks To Resolve Impasse Over Q12 Legal Review This Week

It remains uncertain whether a legal review by the European Commission that since June has delayed public consultation of draft ICH Q12 post-approval changes guideline can be resolved during this week's ICH meeting in Geneva.

Manufacturing Quality

US/EU Agreement Will Reduce Global Import Testing Burden

US drug makers will no longer have to retest batches exported to the EU under a mutual recognition agreement provision expected to take effect by July 2019. It's a landmark development in industry's quest to eliminate import testing, which it says wastes time and resources. But many nations around the world still require import testing – our interactive map shows which rules apply where.

Compliance Manufacturing

US FDA Recognizes Eight EU Authorities, Triggers Mutual Recognition Provisions

US FDA recognizes the drug regulatory authorities for eight of the European Union's 28 member states by a Nov. 1 deadline, triggering key provisions of the landmark mutual recognition agreement.

Compliance Manufacturing
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