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BioWorld - Friday, May 23, 2025
Home » Authors » Mark McCarty

Articles by Mark McCarty

GAO sees need for FDA guidance for organ-on-a-chip

May 22, 2025
By Mark McCarty
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
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U.S. White House

White House eyes 11% cut in FDA budget authority for 2026

May 22, 2025
By Mark McCarty
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
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MHRA logo

MHRA drafting guidance for RW clinical studies control arm

May 21, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.
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U.S. FDA headquarters

GAO sees need for FDA guidance for organ-on-a-chip

May 21, 2025
By Mark McCarty
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Read More
Gavel-and-scales.png

Innovative Health bests J&J unit for anticompetitive practices

May 20, 2025
By Mark McCarty
Innovative Health LLC, of Scottsdale, Ariz., obtained a jury verdict of $147 million against Johnson & Johnson’s Biosense Webster unit for practices that thwarted the use of less costly reprocessed medical devices.
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Spinefrontier CEO enters guilty plea for false statement

May 20, 2025
By Mark McCarty
The U.S. Department of Justice said the CEO of Spinefrontier Inc., Kingsley Chin, entered a guilty plea in connection with allegations that he made false statements about payments made to surgeons for consulting work the physicians did not perform.
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U.S. Capitol building

CMS posts RFI for digital health infrastructure

May 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services reported a request for information for a modernized digital health ecosystem that would presumably improve beneficiary access to digital health technologies.
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Noah Medical

​FDA floods Noah Medical with multi-deviation warning letter

May 14, 2025
By Mark McCarty
Companies new to the world of U.S. FDA regulation are often unaware of how detailed the agency’s inspections are, which might be the case with the October-November 2024 inspection of Noah Medical Inc.
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Product recall concept image

FDA warns ICU Medical for fixes for infusion pump

May 13, 2025
By Mark McCarty
The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems.
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Concept art for prenatal genetic testing and whole genome sequencing.

Noridian eyes coverage of Invitae test panel for heritable aortic disease

May 13, 2025
By Mark McCarty
Noridian Healthcare Solutions opened a draft local coverage determination for gene tests for heritable thoracic aortic disease per a request from Invitae Corp., of San Francisco, which makes a comprehensive panel test for aortopathy.
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