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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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A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device.
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The US Food and Drug Administration (FDA) released a draft guidance “Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” The draft guidance is a combination of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies” and an updated version of the draft guidance from 2015, “Safety Assessment for IND Safety Reporting,” which has been withdrawn. The intent of the draft guidance is to clarify and support sponsors in understanding the requirements for expedited safety reporting.
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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. A recently added question with answer regards the inspection of study participants’ medical records by regulatory authorities in the EU.
Question 15: “Do GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data, even if there is no statement in the ICF establishing that trial participants consent to the review of their medical records and other personal data by EU inspectors?”
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A sub-investigator and an assistant coordinator working at a clinical research site in Florida pleaded guilty to conspiring to falsify clinical trial data. The two stated in their pleas that they conspired with others to make it appear that study participants were enrolled in and participating in two clinical trials when in fact the study data added to the medical records was fabricated and they did not participate in the clinical trials. Sentencing for this case occurs in August.
