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Latest From Bowman Cox
Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.
Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.
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.