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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements.
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The European Medicines Agency (EMA) released a Complex Clinical Trials Questions and Answers guidance document in May 2022. Complex clinical trials (CCT) are defined as “being non-conventional in the sense that they have elements, features, methods or combination thereof, including novel approaches, that confer complexity of their designs, conduct, analyses or reporting.”
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The US Food and Drug Administration (FDA) released a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” late December 2021. The draft guidance provides a framework for assessing if software modeling used to support medical device premarket submissions are credible. Regulatory submissions often lack adequate explanation of the rationale for the models’ credibility for the context of use (COU). The COU is the specific role and scope of the model used to address the “question of interest.”
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The US Food and Drug Administration (FDA) released a draft guidance “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” for public comment in October 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Comment now through January 21, 2022 HERE.