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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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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 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. Several of the questions were previously revised in March 2022. Under section “GCP matters”, questions 16 and 17 were added in late 2022. Question 17 is covered in part 2 of the blog.
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An investigator was recently issued a warning letter due to noncompliance with the IRT, which can impact the safety of the participants and the quality and integrity of the data. Per protocol, IP was to be administered according to hemoglobin levels and the IRT was to randomize the doses appropriately.
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The U.S. Congress reauthorized the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023-2027 on September 30, 2022. PDUFA began in 1992 and must be reauthorized every five years. Starting in 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) included the fifth reauthorization of PDUFA and the third reauthorization of the Medical Device User Fee Act (MDUFA), which began in 2002.
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The U.S. Food and Drug Administration (FDA) released a draft guidance “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers” in November 2022. The regulation governing expanded access went into effect in October 2009, and due to a large volume of questions on how to comply with the regulations, released a guidance documents in June 2016 which was updated in October 2017. After the 2017 guidance, the Agency continued to receive additional questions and changes occurred to the regulation relating to the FDA Reauthorization Act of 2017 (FDARA) and the 21st Century Cures Act (Cures Act).
