Bowman Cox
Executive Editor
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Latest From Bowman Cox
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.
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.
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.
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.
US FDA Pressing Repackers To Disclose API Suppliers In Case Quality Issues Arise
The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.
FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac
Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.