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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

For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites

Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.

Vaccines Quality

The Good, The Bad And The Ugly Of COVID-19 Vaccine Manufacturing Technology Platforms

Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.

Platform Technologies Drug Approval Standards

Expediting The Expedited: How Rolling CMC Review Process Is Working For COVID-19 Vaccines

US, EU and Canadian authorities recently discussed their approaches to rolling reviews of CMC applications for coronavirus vaccines.

Coronavirus COVID-19 Drug Review

How To Host Onsite Drug GMP Inspections Without Spreading The Coronavirus

US FDA suggests meeting with investigators onsite by video instead of in person, moving document rooms outside, avoiding paper and more. UK MHRA shares similar recommendations.

Manufacturing Quality

COVID-19 Contracting Accelerated As US Fiscal Year 2020 Drew To A Close

US government stockpiles more drugs, refines pandemic surveillance with wastewater sampling and more as it braces for winter.

Coronavirus COVID-19 Distribution

Stability Genius: How CMC Section Of COVID-19 Vaccine Guidance Speeds EUAs Safely

By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.

Coronavirus COVID-19 Vaccines
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