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BioWorld - Saturday, July 5, 2025
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Regulatory front
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Regulatory front for April 8, 2021

April 8, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
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Regulatory front for April 7, 2021

April 7, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
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Regulatory front for April 6, 2021

April 6, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
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Architectural pillars

Regulatory front for April 6, 2021

April 6, 2021
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Global Health Innovative Technology Fund, Health Canada, Therapeutic Goods Administration.
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Regulatory front for April 5, 2021

April 5, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
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Regulatory front for April 2, 2021

April 2, 2021
By Meg Bryant
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Infections associated with reprocessed urological endoscopes under investigation.
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Regulatory front for April 1, 2021

April 1, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MDIC accepting applications for the ASC pilot study.
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Regulatory front for March 31, 2021

March 31, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
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Architectural pillars

Regulatory front for March 30, 2021

March 30, 2021
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Gamaleya Institute, Therapeutic Goods Administration.
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Regulatory front for March 30, 2021

March 30, 2021
By Holland Johnson
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, other stent graft products in line for FDA panel safety probe; New conditions imposed on vaccine authorization; MRNA vaccine efficacy holds in real world; STIs on the rise in U.S.
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