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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

How US FDA Will Unleash Attack On COVID-19 Variants Once Global Consensus Is Reached

Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.

Manufacturing Quality

The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements

PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.

Manufacturing Quality

Newly Aligned Teams Sped US FDA’s Drug Quality Reviews Over Pandemic Hurdles

Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented inspections.

Drug Review Manufacturing

Preparing For The Return Of US FDA Inspections

Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.

FDA Manufacturing

How Operation Warp Speed Helps Clear Obstacles To COVID-19 Vaccine Production

Military workers filling in for quality control, manufacturers comparing supply lists, other measures to accelerate the manufacturing pace are noted in US congressional advisory group's report.

Coronavirus COVID-19 Manufacturing

Hiding Cancer Drug Manufacturing Records Costs Fresenius Kabi $50M In US Settlement

It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.

Manufacturing Quality
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