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BioWorld - Friday, June 19, 2026
Home » Topics » Regulatory » Policy

Policy
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Pen and paper

White House ushering in new era of EO governance?

Oct. 15, 2025
By Mari Serebrov
No Comments
While the pace of executive orders (EOs) coming out of the White House has slowed, the Trump administration is still churning them out. As of the end of the third quarter, President Donald Trump had issued 209 EOs. Of those, BioWorld tracked 37 that directly impact drug and device R&D, regulatory burdens, pricing and market competition.
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U.S. Capitol building, Washington D.C.

US federal shutdown bites FDA

Oct. 13, 2025
By Mark McCarty
The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.
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Digital globe illustrating pharma trade, tariffs

Rx tariff a stick and a carrot for US price, onshoring deals

Oct. 13, 2025
By Mari Serebrov
No Comments
Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains, serving as both a stick and a carrot to get drug companies to come to the table with their best deals.
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Vaccine vial and syringe

Latest ACIP recommendations added to CDC vaccine schedules

Oct. 7, 2025
By Mari Serebrov
No Comments
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
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Vaccine vial and syringe

Latest ACIP recommendations added to CDC vaccine schedules

Oct. 6, 2025
By Mari Serebrov
No Comments
Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
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Global vaccine illustration

So far, ACIP vaccine recommendations in line with the world

Oct. 2, 2025
By Mari Serebrov
No Comments
While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.
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100 percentage illustration

Trump hits drug imports with 100% tariffs, starting Oct. 1

Sep. 30, 2025
By Karen Carey and Nuala Moran
No Comments
The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”
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Prescription bottle with dollar sign shadow

MFN pricing model under White House review

Sep. 26, 2025
By Mari Serebrov
No Comments
As President Donald Trump promised again in a Sept. 23 media briefing, most-favored-nation (MFN) prescription drug pricing could soon come to America.
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100 percentage illustration

Trump hits drug imports with 100% tariffs, starting Oct. 1

Sep. 26, 2025
By Karen Carey and Nuala Moran
No Comments
The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”
Read More
Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

US expands tariff investigations into med tech, robotics, diagnostics

Sep. 25, 2025
By Annette Boyle
The Trump administration has launched an investigation into the national security effects of imports of medical equipment, devices, consumables and equipment, laying the groundwork for a potential increase in tariffs targeting the industry. A separate investigation into robotics and industrial machinery began the same day. Med-tech stocks dropped significantly in response to the news as investors fear increased tariffs on the sector. In April, the administration initiated a similar review of the pharmaceutical industry and in August threatened 200% tariffs on that sector.
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