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FDA Could Release GMP Data To Prod Manufacturing Improvements

 
• By Derrick Gingery

Batch failure and other measures commonly tracked by manufacturers could be aggregated into an industry-wide index that FDA would use to help make risk-based inspection decisions.

FDA may inform its facility inspection decisions using data that would be provided by industry and combined into a publicly available index, thanks to a drug supply chain security provision in FDASIA.

Fairly common measures such as batch failure, right-first-time, out-of-specification rates and other measures that most, if not all, manufacturers track,...

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Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
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• By Sarah Karlin-Smith

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