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BioWorld - Monday, June 1, 2026
Home » Topics » Regulatory » Policy

Policy
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Scissors cutting a row of black and red paper dolls

Still waiting for the dust to settle at US FDA, throughout HHS

Feb. 20, 2025
By Mari Serebrov
With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).
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US flag with microscope

Trump administration an existential threat to science, warns AAAS chief

Feb. 19, 2025
By Nuala Moran
The scientific establishment has launched a fight back against the Trump administration and the slew of executive orders that threaten to dismantle research funding, with a warning that the next month could be critical for the future of U.S. science.
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Various pills laid across a target

Pharmaceuticals named as tariff target, starting at 25%

Feb. 19, 2025
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
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Infant exam

China prioritizes mental health, pediatric care in 2025

Feb. 19, 2025
By Marian (YoonJee) Chu
China’s National Health Commission is designating a three-year period from 2025 to 2027 as the “years of pediatric and mental health services,” in line with a new pledge to achieve eight initiatives in the health care sector aimed at servicing underserved populations.
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Monica Bertagnolli, former director, U.S. NIH
Policy

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 19, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
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Monica Bertagnolli, former director, U.S. NIH

AAAS 2025: Former NIH head Bertagnolli sounds warning on funding cuts

Feb. 18, 2025
By Nuala Moran
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17.
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Hand holding a pink slip or termination notice against a blurred office background

Thousands of US HHS staff terminated in name of efficiency

Feb. 18, 2025
By Mari Serebrov
As part of a U.S. government-wide reduction in force aimed at restructuring and streamlining federal agencies, 5,200 Health and Human Services employees reportedly received their pink slips over the weekend, with 1,165, or 22%, of those at the NIH.
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Guillain-Barré case puts Moderna norovirus vax trial on hold

Feb. 14, 2025
By Karen Carey
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
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Doctor with brain illustration, businessman with dollar sign illustration
Analysis

NIH funding plans threaten to derail ‘synergistic partnership’

Feb. 13, 2025
By Anette Breindl
A 15% cap on indirect cost reimbursement that was announced by the U.S. NIH has been stalled by a court order for the time being. But researchers remain deeply concerned about the attempt, and about the new administration’s adversarial approach to research and universities.
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Regulatory-US-FDA-HQ.png

Uncertainty builds amid Kennedy confirmation, Trump’s orders

Feb. 13, 2025
By Mari Serebrov
Coming as no surprise, the U.S. Senate’s Feb. 13 confirmation of Robert Kennedy as the next secretary of the Department of Health and Human Services (HHS) did nothing to ease the uncertainty hanging over the FDA and other HHS agencies.
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