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On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.
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In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.
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On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.
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On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.
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On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.
A warning letter was issued to Dr. Evelyn Lopez-Brignomi, M.D. this March in regards to “objectionable conditions observed during an FDA inspection conducted at her clinical site between June 8 and June 23, 2020.” This study contained pediatric subjects who are a vulnerable population which raises concern about the severity of the violation and their potential impact on subjects’ rights, safety, and welfare.
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There has been an increase in the complexity of clinical trials over the last decade. Add to that the support for including more diverse populations who may have additional underlying conditions (FDA Guidance document “Enhancing the Diversity of Clinical Trial Populations”), and this leads to an increase in the number of safety events reported.
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Overview of 21 CFR 54 Financial Disclosure & Part 11 Electronic Data Signatures interactive eLearning is now available for purchase in our online store HERE.
This interactive eLearning can be used alone or as part of the full curriculum (see more below).
The course provides an overview of the key concepts and best practices for following the U.S. Food and Drug Administration’s (FDA) applicable regulations for financial disclosure, electronic records, and electronic signatures. These topics are applicable to drug, device, and biologic studies. Required by 21 CFR Part 54, sponsors must request certain financial information from clinical investigators, who are performing their studies before a marketing application is submitted. 21 CFR Part 11describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and/or use electronic signatures.
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The 21st Century Cures Act (PUBL255.PS (congress.gov), established December 13, 2016 “is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to them.” The Cures Act section 505F included the potential use of Real World Evidence (RWE). According to the FDA, Real World Evidence is “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials and the “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.” download (fda.gov) RWE establishes its evidence by using Real Word Data from medical billing claims, electronic health records, clinical registries, and mobile devices. This strategy provides more information on the safety and efficacy of a device beyond the limitations of a clinical trial.
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Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning
An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB interactive eLearning is now available for purchase in our online store HERE. The interactive eLearning course provides an overview of the key concepts and best practices for maintaining human subject protection (HSP) by following the U.S. Food and Drug Administration’s (FDA) applicable regulations. Conduct of a clinical trial involving human subjects includes considerations to protect their rights and safety. Ensuring HSP is a core principle of Good Clinical Practice (GCP) and is required by regulatory authorities. Understanding how to implement these FDA regulations applicable to clinical research is key to a successful and ethical clinical trial.
