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Bowman Cox
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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.
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.
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.
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.
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.
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.