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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

The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility

FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.

Manufacturing Quality

The Quality Lowdown: What Inopak, Dong Juan And Sofex Must Do To Comply

In this week's must-read Quality Lowdown: A New Jersey firm must investigate antibacterial foam that wasn’t, a Chinese firm must validate its OTC spray, a Portuguese firm must establish a quality system, and FDA must get forensic help if it is to understand certain drug-related deaths.

 

Manufacturing Quality

How Coherus Overcame FDA’s Doubts About Udenyca Immunogenicity

Better immunogenicity assays overcame concerns raised in complete response letter for Udenyca, leading to approval of the Neulasta biosimilar.

Biosimilars Drug Review

The Quality Lowdown: No Excuses For Homeopathic, CMO, OTC Quality Failures

US FDA assigns blame for quality failures at mostly US-based homeopathic, contract manufacturing and OTC firms, while WHO approves growing manufacturing plant in Kenya.

Quality Compliance

US FDA Budget Boost Would Increase Domestic Drug Manufacturing By Better Regulating New Technologies

FDA’s fiscal year 2020 budget request calls for spending on figuring out how to regulate new drug manufacturing technologies under the rubric of increasing US domestic manufacturing.

Quality Compliance

FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence

The US FDA’s FY 2020 budget request calls for funding to help advance the emerging drug compounding outsourcing sector, as did the FY 2019 request. The money would bring more training, specially tailored GMP requirements and a center of excellence.

Quality Regulation
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