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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

Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.

Quality Manufacturing

The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits

In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.

Compliance Manufacturing

FDA Gets Final With Guidance On Recall Public Warnings, Notifications

There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.

Recalls Manufacturing

Recall-Related Public Warnings Get Final US FDA Guidance

There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.

Product Recalls Quality

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

The Post-Shutdown Quality Lowdown

Quality oversight activity began ramping back up after the partial US government shutdown, even as EU oversight activities entered into a Brexit-related slowdown.

Compliance Manufacturing
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