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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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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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The US Food and Drug Administration (FDA) released a guidance “Refuse to Accept Policy for 510(k)s” in April 2022. This guidance was originally issued in May 1994 and was previously updated in September 2019. The guidance describes the procedures the FDA uses to determine if a medical device premarket notification (510(k)) meets the minimum threshold of acceptability for their regulatory review.
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The US Food and Drug Administration (FDA) released a draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” for comment in April 2022. The draft guidance, when finalized, will modernize premarket expectations for medical devices with advanced connection technologies that may pose a cybersecurity risk. The draft guidance also describes cybersecurity medical design, labeling, and recommended documentation to be included in premarket submissions for devices with a cybersecurity risk.
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The European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) issued advice to sponsors on how to manage clinical trials that are impacted by the Russian invasion of Ukraine. Sponsors requested advice on how to manage protocol deviations, source documents, missing data, and other changes that are due to the ongoing Ukrainian war.
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The US Food and Drug Administration (FDA) published a press release confirming that the FDA and medical device industry stakeholders reached an agreement on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Amendments of 2023 (MDUFA V). The first authorized user fee for medical device occurred with the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
