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Home » Topics » Regulatory front

Regulatory front
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Regulatory front for Feb. 5, 2021

Feb. 5, 2021
By Marie Powers
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EMA initiates OPEN collaboration; NICE evaluating guidance processes; Florida researcher indicted.
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Regulatory front for Feb. 4, 2021

Feb. 4, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CEO tells patients their deaths were impending for profit; DeGette, Bucshon ink new testing legislation; NICE: Acupath’s URO17 test needs more data.
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Regulatory front for Feb. 3, 2021

Feb. 3, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
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Regulatory front for Feb. 2, 2021

Feb. 2, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC reports on cases, sequencing; NICE says savings seen with Cytosorb; IP at issue as WTO pushes for global pandemic effort; Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
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Regulatory front for Feb. 1, 2021

Feb. 1, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA unveils policy concerns for 2021; NRC seeks nominees for medical isotopes adcomm; Senators: More protection needed for genomic data; Veterans’ genomic data put at risk; DNA sequencing claims struck down.
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Regulatory front for Jan. 29, 2021

Jan. 29, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reissues policy for coagulation systems; FDA announces recall of Penumbra’s Jet 7; Stericycle to buy buses as part of settlement; Athena agrees to $18M fine; WHO refreshes essential diagnostics list; TGA pulls two pandemic-driven exemptions.
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Regulatory front for Jan. 28, 2021

Jan. 28, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
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Regulatory front for Jan. 27, 2021

Jan. 27, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada updates list of recognized standards; FTC posts draft consent agreement for Flo Health; Two more snared in PGx testing scam.
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Regulatory front for Jan. 27, 2021

Jan. 27, 2021
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Jan. 26, 2021

Jan. 26, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
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