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AgencyIQ
757 posts
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AgencyIQ
@AgencyIQ
Regulatory intelligence, simplified. Discover a new way to explore the people, policy, and processes shaping the modern #FDA regulatory environment.
Washington, DC
agencyiq.com
Дата регистрации: January 2020
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  • user avatar
    AgencyIQ
    @AgencyIQ
    4 сент. 2024 г.
    Seven years after its inception, the FDA has finalized its first guidance on the Voluntary Malfunction Summary Report (VMSR) program for medical devices. Read our analysis here: bit.ly/4gfmB7g #AgencyIQ #Politico #LifeSciences #FDA #Regulation #MedicalDevices
    Graphic image with text announcing FDA finalizes guidance allowing certain device makers to submit quarterly malfunction reports. The source is AgencyIQ and the author is Laura DiAngelo, MPH.
    540
  • user avatar
    AgencyIQ
    @AgencyIQ
    30 авг. 2024 г.
    Courtney Lias has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of Tim Stenzel at the end of 2023. Recently she confirmed she is now the permanent Director. Read our analysis: bit.ly/3yZwGnP #AgencyIQ #Politico #FDA
    305
  • user avatar
    AgencyIQ
    @AgencyIQ
    28 авг. 2024 г.
    ECHA has issued a new guide for NEAs, clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures. Read more: bit.ly/47lmz9T #AgencyIQ #Politico #Chemicals #ECHA
    169
  • user avatar
    AgencyIQ
    @AgencyIQ
    27 авг. 2024 г.
    Over a year since its initial draft guidance document on the use of PCCPs for medical devices that leverage machine learning, the agency has issued a new draft guidance on the use of PCCPs for all medical devices. Read more: bit.ly/3T12K1h #AgencyIQ #Politico #CDRH
    138
  • user avatar
    AgencyIQ
    @AgencyIQ
    26 авг. 2024 г.
    Don't miss out! Register here: bit.ly/4dhsJd2 to join us on tomorrow, Tuesday, August 27, at 12pm ET, for a free and informative webinar where AgencyIQ’s research team will discuss the what the FDA still has on its plate in 2024. #AgencyIQ #Politico #FDA #Webinar
    106