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BioWorld - Sunday, January 11, 2026
Home » Topics » Regulatory » Legislation

Legislation
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U.S. Capitol building, Washington D.C.

New legislation would apply product liability principles to AI

Jan. 6, 2026
By Mark McCarty
Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.
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U.S. Capitol building

US Senate ends 2025 with no gift for kids with cancer

Dec. 23, 2025
By Mari Serebrov
No Comments
After being unanimously passed by the U.S. House Dec. 1, the bipartisan Mikaela Naylon Give Kids a Chance Act seemed to be headed for sure passage in the Senate before it adjourned late last week.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 16, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 15, 2025
By Mari Serebrov
No Comments
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
Read More

US pediatric voucher making moves in Congress

Dec. 2, 2025
By Mari Serebrov
No Comments
The next stop on the comeback tour for the U.S. FDA’s Rare Pediatric Disease Priority Review Voucher program is the Senate, after the House unanimously passed the Mikaela Naylon Give Kids a Chance Act, H.R. 1262, Dec. 1.
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Emulate Chip R1 Brain

US, European biotechs lead budding organ-on-a-chip market

Nov. 20, 2025
By Marian (YoonJee) Chu
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.
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Emulate Chip R1 Brain

US, European biotechs lead budding organ-on-a-chip market

Nov. 19, 2025
By Marian (YoonJee) Chu
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.
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Amended stopgap spending bill includes full 2026 funding for FDA

Nov. 12, 2025
By Mari Serebrov
No Comments
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
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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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Patent law book and gavel

US Congress seeks to undo IP damage wrought by Supreme Court

Oct. 9, 2025
By Mari Serebrov
No Comments
A yearslong bipartisan effort to end the patent-eligibility chaos the U.S. Supreme Court created more than a decade ago could finally come to fruition with the current Congress.
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