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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.
Background
Women were underrepresented at under 20% of subjects in clinical trials in the 1990s.
The Food and Drug Administration (FDA)’s Office of Women’s Health (OWH) was formed in 1994 with a mission to ensure adequate involvement of women in clinical trials and to identify specific requirements and challenges for women’s health.
Clinical Trials Day recognizes clinical trials professionals’ contributions to the advancement of medicine and public health. It is celebrated yearly on May 20th globally in remembrance of what is believed to be the first randomized clinical trial. During a time when scurvy killed many at sea, James Lind, the surgeon aboard the HMS Salisbury of Britain’s Royal Navy, devised a “study” involving 12 men given one of six different treatments in May 1747. Those who were given citrus showed improvement. This is regarded as the beginning of clinical trial design.
There are concerns over how the United Kingdom’s (UK) departure from the European Union (EU), also known as Brexit, will affect clinical research stakeholders in the UK and the EU. Brexit will begin March 29, 2019. Since the European Medicines Agency (EMA) is a EU Agency, would that mean that the UK would no longer be a part of the Agency or follow the regulations set by it? What effects would the change have on harmonization of clinical trials through Europe and globally?
How does Brexit affect the EMA headquarters, and will it remain independent?
The US Department of Health and Human Services along with 16 other agencies published a Notice of Proposed Rulemaking (NPRM) to delay the compliance date of the updated “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” published in the Federal Register on January 19, 2017. The January 2017 final rule is also known as the “2018 Requirements.”
