Bowman Cox
Executive Editor
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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.
Woodcock: The US FDA Sets The Stage For Global Quality Dossiers
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
Human-Machine Interface Ratted On Apollo Workers Who Fibbed Batch Data
The US FDA applied laboratory data integrity inspection technique to production floor, leading to warning letter, import alert.
Don’t Let Trade Issues Interfere With Drug Inspection Coordination, Experts Say
US National Academies panel diverges on how to focus pharmaceutical inspectorates’ mutual reliance arrangements on public health goals.
US FDA Could Use More Foreign Investigators If It Could Find Them, Woodcock Says
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.