Article FDA Informed Consent 
Hall Render
OCTOBER 5, 2023
Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.
Bill of Health
JULY 14, 2023
The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.
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Hall Render
SEPTEMBER 14, 2023
Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.
Bill of Health
DECEMBER 20, 2022
FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”
Healthcare IT Today
AUGUST 9, 2022
The following is a guest article by Natalie C. The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Oehlers, Associate Attorney and Carly C. About Natalie C. About Carly C.
SQA
MAY 17, 2022
For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). United States Food and Drug Administration (FDA) – Regulations and Guidances.
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).
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