Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says
Quarantines, travel restrictions and supply chain interruptions are likely to cause "unavoidable protocol deviations" in ongoing clinical trials, the FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by COVID-19.
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The EU is addressing the regulatory obstacles that threaten to reduce the speed at which vital products needed to treat COVID-19 are produced.
COVID-19: US FDA’s Hahn Slams The Brakes On Domestic Inspections ‘For The Health And Well-Being Of Our Staff’
A little more than a month after it put the kibosh on conducting facility inspections in China, the agency announced late on 18 March that it was suspending routine surveillance audits in the US, too.
‘Full-Speed Ahead’: Trump Invokes Korean War Era Law To Fight COVID-19, Shaking Up US Device Manufacturing
Calling himself a “wartime president,” Donald Trump on 18 March invoked the Defense Production Act to push US manufacturers to produce medical products needed to combat COVID-19 – even if those companies aren’t device makers. Trump later signed an Executive Order giving Health and Human Services secretary Alex Azar the power to “allocate materials, services and facilities as deemed necessary or appropriate” – all actions covered by the DPA.