Top Stories of 2015
This article was originally published in The Gold Sheet
Data integrity was the top story of 2015, followed by quality metrics and sterile injectables contamination.
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Microbial and particulate contamination drove drug recalls to historic levels for a fifth year in 2014, FDA recall data shows. But the data still falters in identifying the weakest links in global pharmaceutical supply chain quality.
Pfizer’s plan to acquire Hospira is part of a turnaround trend in which Big Pharma hopes its quality will rub off on the troubled generics injectables sector. The question is: Will it work?
BARDA’s consortium approach scrutinized as industry recovers from US Defense Production Act rated orders. Questions of sustainment fees, interruptible commercial activities explored during BioMaC Industry Day call as agency emphasizes need for proven capacity.