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Home » Topics » Regulatory » Legislation

Legislation
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Shipping container with flag of China

Bipartisan group of lawmakers eye China in US manufacturing legislation

March 8, 2024
Several members of the U.S. Congress have inked legislation that provides taxpayer resources to help bring many types of manufacturing, including medical devices and equipment, back to the Western Hemisphere in general and, in some instances, the U.S.
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China and U.S. flags

Stuff of ‘science fiction’ driving US-China biotech race

March 7, 2024
By Mari Serebrov
Superhuman soldiers. Designer babies. Genetically tailored weapons. Mind-control. A foreign database containing the DNA of every person on the planet. The list reads like the plot of a science fiction horror story, but there’s no fiction involved. These are real threats from China raised by members of the U.S. House Select Committee on the CCP (Chinese Communist Party) at a March 7 hearing on the growing stakes of the bioeconomy and American national security.
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U.S. flag and money

US Congress still struggling with FY 2024 spending bills for FDA

Feb. 26, 2024
By Mark McCarty
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
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Environmental Protection Agency - US EPA

US House committee sends signal to EPA on EtO regulation

Feb. 15, 2024
By Mark McCarty
The ongoing saga of the Environmental Protection Agency’s (EPA) pending rule on ethylene oxide (EtO) made its way to a Feb. 14 hearing in the U.S. House of Representatives, which included the testimony of Lishan Aklog of Pavmed Inc., who warned that a significant curtailment of EtO as a sterilant for medical devices could hamper patient access to medical devices.
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Health professional reviewing digital health data

US Senate evaluates site-specific use of AI in health care

Feb. 8, 2024
By Mark McCarty
Many health care facilities in the U.S. have deployed artificial intelligence (AI) algorithms that are tailored for the patient population seen in those clinical settings, a practice that avoids FDA regulation by removing the question of commercial distribution.
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U.S. flag, stethoscope

Budget scoring a concern for breakthrough device coverage legislation

Feb. 7, 2024
By Mark McCarty
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
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Digital brain and silhouette

FDA’s device center meets MDUFA hiring goals in fiscal 2023

Jan. 25, 2024
By Mark McCarty
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
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U.S. Capitol building

New effort to reform patent eligibility in play in US Senate

Jan. 24, 2024
By Mark McCarty
The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies.
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Microscope with beakers and flasks

Advamed wary of government plan to privatize US helium depot

Jan. 23, 2024
By Mark McCarty
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.
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U.S. Capitol building

US FDA rolls out companion diagnostic pilot to overcome LDT problem

Jan. 2, 2024
By Mark McCarty
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
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