Nov 26, 2018

FDA to modernize how it clears medical devices

Caitlin Owens, author of Vitals

FDA Commissioner Scott Gottlieb during a tour of University of Colorado Hospital's emergency department. (Photo: RJ Sangosti/The Denver Post via Getty Images)

The Food and Drug Administration is moving away from using comparisons with much older products on the market to clear new medical devices, according to the Wall Street Journal.

Why it matters: The existing method has been criticized, as many of the products being used to clear new devices are decades old and new products aren't subject to full studies. The agency said that if the comparison method continues to be used, companies will be driven toward analyzing new products against devices no more than 10 years old.

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Inside Trump's antifa tweet

President Trump at Cape Canaveral on May 30. Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

As recently as Saturday night, senior administration officials told me that the designation of a violent cohort of far-left activists, antifa, as a terrorist organization was not being seriously discussed at the White House. But that was Saturday.

Behind the scenes: The situation changed dramatically a few hours later, after prominent conservative allies of the president, such as his friend media commentator Dan Bongino, publicly urged a tough response against people associated with antifa (short for "anti-fascist").

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Protests continued across the country for the sixth day in a row on Sunday, as demonstrators called for justice in response to the deaths of George Floyd, EMT Breonna Taylor, jogger Ahmaud Arbery and countless other black Americans who have suffered at the hands of racism and police brutality.

What's happening: Protestors in D.C. broke one police barricade outside the White House on Sunday evening after reportedly demonstrating for several hours. The atmosphere was still largely peaceful as of 6pm ET.

Trump privately scolded, warned by allies

Illustration: Aïda Amer/Axios. Photo: Win McNamee/Getty Images

Over the past couple of days, numerous advisers both inside and outside the White House have urged the president to tone down his violent rhetoric, which many worry could escalate racial tensions and hurt him politically.

Behind the scenes: The biggest source of internal concern was Trump's escalatory tweet, "when the looting starts, the shooting starts." Some advisers said it could damage him severely with independent voters and suburban women.