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BioWorld - Thursday, May 28, 2026
Home » Topics » Regulatory » Policy

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Businessman signing documents

Trump’s executive orders stacking up, along with challenges

Feb. 7, 2025
By Mari Serebrov
Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.
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U.S. flag and White House podium

Trump administration presents a mixed picture for med tech

Feb. 7, 2025
By Mark McCarty
The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.
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FDA website and logo

Doctors group sues US CDC, FDA, HHS over data takedown

Feb. 5, 2025
By Mari Serebrov
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
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Medicare puzzle

MedPAC not ready to move on Medicare site-neutral payments

Feb. 5, 2025
By Mark McCarty
Site neutral payments under the U.S. Medicare program have been contentious for some time, and Congress seems poised to act on the issue in 2025. The Medicare Payment Advisory Commission is wary of making any recommendations as yet — a position that MedPAC may hold pending the collection of additional data.
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U.S. flag, stethoscope

Industry supportive of CMS move to tighten MA plans’ coverage

Feb. 5, 2025
By Mark McCarty
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
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