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Regulatory front
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Regulatory front for March 5, 2021

March 5, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDSCO eyes recognition of ASTM standards; Device makers, docs blast radiation oncology payment model.
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Regulatory front for March 4, 2021

March 4, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: AHRQ: Patient portals underused in ED visits; Butterfly IQ scores well on cost, but supporting data limited.
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Regulatory front for March 3, 2021

March 3, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO reviews FEMA's pandemic supply chain management efforts; Testing lab owner sentenced to three years; Health Canada renews interim order for importation of devices; FDA: claims of registration certificates may be misleading; MDCG issues gap guidance pending Eudamed completion; FDA seeking nominations for advisory committee.
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Regulatory front for March 3, 2021

March 3, 2021
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma.
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Architectural pillars

Regulatory front for March 2, 2021

March 2, 2021
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: FDA, Gilead Sciences, Therapeutic Goods Administration, World Health Organization.
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Regulatory front for March 2, 2021

March 2, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
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Regulatory front for March 2, 2021

March 2, 2021
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for March 1, 2021

March 1, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
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Regulatory front for Feb. 26, 2021

Feb. 26, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neovasc snares second patent term extension; CMS drops CT image quality proposal; TGA opens docket for nanomaterials regulation; ATA supports OIG statement on telehealth.
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Regulatory front for Feb. 25, 2021

Feb. 25, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
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