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BioWorld - Monday, March 30, 2026
Home » Topics » Regulatory » Legislation

Legislation
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Hand holding money plant

Wait almost over, as SBIR nears reauthorization

March 24, 2026
By Mari Serebrov
No Comments
A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.
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Compounded weight-loss drugs hit on every side

Feb. 9, 2026
By Mari Serebrov
No Comments
True to its word, Novo Nordisk A/S filed a patent infringement lawsuit in U.S. district court against Hims & Hers Health Inc. over compounded versions of Novo’s semaglutide products.
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NIH Biomedical Research Center

Unburdening the past, HELPing NIH advance the future

Feb. 5, 2026
By Mari Serebrov
No Comments
In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.
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Senators, experts agree country of origin not an Rx trade secret

Jan. 29, 2026
By Mari Serebrov
No Comments
The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.
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U.S. Capitol building

Fiscal 2026 HHS spending bill in jeopardy?

Jan. 26, 2026
By Mari Serebrov
No Comments
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.
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Exterior of NIH Vaccine Research Center

Legislation seeks to guard NIH from politicization

Jan. 23, 2026
By Mari Serebrov
The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency.
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U.S. Capitol and $100 bills

NIH spared slash-and-burn in congressional spending agreement

Jan. 21, 2026
By Mari Serebrov
No Comments
The good news is that the U.S. Congress is on track to pass a slate of fiscal 2026 spending bills before the current continuing resolution expires Jan. 30. So, barring any last-minute disputes or legislative hostage-taking, there should be no repeat of last year’s 43-day shutdown that impacted NIH grants and activities.
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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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