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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. By David B.

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Planning for the End of the COVID-19 Public Health Emergency

FDA Law Blog

The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. FDA provides FAQs about what happens to EUAs when a public health emergency ends (see here ). We all look forward to the end of the COVID-19 pandemic.

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