FDA CDER Compliance Office Answered Pandemic With Fewer Inspections, Greater Discretion
Fewer inspections but more warning letters, import alerts and drug-shortage discretions were seen as office sought to ameliorate COVID-19 impacts.
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Preparing For The Return Of US FDA Inspections
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.
Is Another Heparin Crisis Looming? Congress Raises Alarm, Demands US FDA Briefing
The FDA must explain how it will prevent heparin adulteration as a virus kills pigs in China again.