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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 International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.
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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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The European Medicines Agency (EMA) Good Manufacturing Practice Frequently Asked Questions (FAQ) webpage offers guidance on good manufacturing practice (GMP) and good distribution practice (GDP). Previous revisions in February and October 2022 were relating to veterinary medicinal products.
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Beginning January 31, 2023, the Clinical Trials Information System (CTIS) is required for all new clinical trial applications that are applicable to the European Medicines Agency (EMA). The Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) entered into application January 31, 2022, which also launched the CTIS.
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The US Food and Drug Administration (FDA) released a draft guidance “Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products” for public comment in November 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). A good source of RWE, a registry is an “organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.”
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The US Food and Drug Administration (FDA) is holding a public meeting to discuss recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA). Stakeholders are invited to discuss their opinions on recommended enhancements for the next reauthorization. PDUFA began in 1992 and must be reauthorized every five years.
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Many people automatically think about drugs when they visualize clinical trials, especially if that has been their experience. Medical devices are essential for human health and it is important to understand how they are distinct from drugs. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:
