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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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.

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Embracing Technology: FDA Releases Draft Guidance on Decentralized Clinical Trials

Hall Render

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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How to Mitigate Ethical Challenges of AI-Driven Healthcare

Healthcare IT Today

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. . Another major ethical concern of AI use surrounds the principle of informed consent. Overall Recommendations .

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Overcoming Key Hurdles in Decentralized Trials with Better Education

HIT Consultant

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. Improving Protocol Compliance.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 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).

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. has no power to enforce compliance”), aff’d , 405 F.

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