• Small/Mid-size MedTechfirms productivity challenge; Lessons learned

    20 September 2023 MedTech
    Improvements in labor productivity have been the engine of economic growth. But in the past 15 ...
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    Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2023

    19 September 2023 Devices Regulatory Updates
    USA | EUROPE | ASIA USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, ...
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  •

    BioPharma – USA/Europe/Asia Regulatory Updates, Sept 2023

    19 September 2023 Pharma Regulatory Updates
    USA | EUROPE | ASIA USA (FDA) Guidances Released on EPCIS Standard for DSCSA Compliance, ...
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  •

    Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, July 2023

    18 August 2023 Devices Regulatory Updates
    USA | EUROPE | ASIA USA (FDA) Medical Device User Fee Rates for Fiscal Year 2024 The ...
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  •

    BioPharma – USA/Europe/Asia Regulatory Updates, Aug 2023

    18 August 2023 Pharma Regulatory Updates
    USA | EUROPE | ASIA USA FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees ...
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  •

    EO Sterilization; EPA Mandate; Alternates from FDA

    7 August 2023 FDA Updates
    In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from ...
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