FDA Law
FEBRUARY 27, 2025
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.
BMJ
AUGUST 20, 2021
Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Digital uptake is more prevalent in high-volume and urban hospital networks.
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Physician's Weekly
JUNE 24, 2025
has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. A connection to dementia will require further research, and Geldsetzer is trying to raise philanthropic funding for a clinical trial. The new studies are coming at a fraught political moment.
FDA Law
AUGUST 29, 2021
The federal government does its own version of rebranding with each change in administration. electronic formatting for regulatory submissions), scientific (e.g., clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., recalls), and the COVID-19 emergency.
FDA Law
OCTOBER 7, 2024
FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. If FDA is prohibited from pursuing the relatively small dollar value tobacco penalty cases administratively, it could affect enforcement.
Permanente Medicine
MAY 20, 2025
Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. I know for a fact that the government or legislators looked to us in Permanente.
FDA Law
JANUARY 5, 2023
FDA counsels that, as is the case with any other electronic device, seemingly small, routine steps like software maintenance and updates are ways companies can address possible vulnerabilities that could lead to adverse events. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices.
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