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Tag: Proposes

Pelosi proposes experts review a president’s mental fitness under 25th Amendment

October 9, 2020
| No Comments
| Fitness

House Democrats, who have accused President Donald Trump of acting erratically as he battles the coronavirus, on Friday introduced a proposal to establish a panel to determine a president’s fitness for office under the Constitution’s 25th Amendment.

The move comes after House Speaker Nancy Pelosi said Thursday that Trump was in an “altered state,” but said Friday the measure wouldn’t apply to him.

“This is not about President Trump. He will face the judgment of the voters. But he shows the need for us to create a process for future presidents,” Pelosi told reporters at Capitol Hill news conference as she introduced the bill.

“This legislation applies to future presidents, but we are reminded of the necessity of action by the health of the current president,” she added. “It’s not about any of us making a judgment about the president’s well-being.”

When pressed by reporters if she thinks it’s time

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FDA Proposes Withdrawing Makena’s Approval

October 6, 2020
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| Health

Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA).

The drug, hydroxyprogesterone caproate injection, was approved in 2011 to reduce the risk of preterm birth in women who had had previous spontaneous preterm birth. The FDA approved the medication under an accelerated pathway that required another trial to confirm clinical benefit.

The required postmarketing study “not only failed to demonstrate Makena’s benefit to the neonate, but also failed to substantiate any effect of Makena on the surrogate endpoint of gestational age at delivery that was the basis of the initial approval,” Patrizia Cavazzoni, MD, acting director of the CDER, wrote in a letter to AMAG Pharma USA, which markets Makena. The letter also was sent to other companies developing products

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