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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

US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Quality Enforcement

Early GMP Compliance Seen As A Key To Avoiding Complete Responses

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Manufacturing Quality

Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies

Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.

Quality Manufacturing

A Warning Letter Trend Surprise: Good In India, Bad In South Korea

A comparison of US FDA inspection and warning letter rates find India performs much better than China and South Korea.

Quality Enforcement

US FDA Questions Valisure’s Zantac Carcinogenicity Findings

As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.

Manufacturing Quality

EMA Fee Revisions Expected To Resolve EC's Objections To ICH Q12 Guideline

Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.

Compliance Quality
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