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Latest From Bowman Cox
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 comparison of US FDA inspection and warning letter rates find India performs much better than China and South Korea.
As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.
Reducing dependence on Type II variation fees would free lifecycle management guideline from European Commission’s legal concerns.
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.
Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.