European Commission Would Harmonize Manufacturing Change Regulations
This article was originally published in The Gold Sheet
Variations criteria would not vary under EC proposal.
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To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.