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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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In June 2023, the U.S. Food and Drug Administration (FDA) issued a permanent debarment as required under the FD&C Act due to the grounds that the individual was convicted of a felony. The individual worked as a coordinator at a clinical site on studies over a variety of therapeutic areas. Their delegated tasks included administering procedures and maintaining case histories of the study participants.
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The US Food and Drug Administration issued a draft guidance on “Psychedelic Drugs: Considerations for Clinical Investigations” in June 2023. Psychedelics are a new horizon development potential in clinical trials. As more sponsors and sponsor-investigators move towards psychedelic drug development as a new psychiatric therapy, questions arise about the best way to move forward within the regulatory framework for clinical trials.
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The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.
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The U.S. Food and Drug Administration (FDA) announced that the “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” draft guidance is available for comment. When finalized, the draft guidance fulfills the requirement for guidance on decentralized clinical trials under Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA).
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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023 and is open for public consultation. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway.
