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Latest From Bowman Cox
The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan
Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
The US FDA applied laboratory data integrity inspection technique to production floor, leading to warning letter, import alert.
US National Academies panel diverges on how to focus pharmaceutical inspectorates’ mutual reliance arrangements on public health goals.
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.