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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.
Meeting: “Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH).”
The Food and Drug Association (FDA) and Health Canada will be holding a Joint Public Consultation meeting.
What does that mean for the informed consent process for clinical trials?
Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard.
China Food and Drug Administration (CFDA) was accepted as a regulatory member in the International Council for Harmonisation (ICH) whose mission “is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.”
Registration now open!
Certification Exam Prep Course
Presented by: Laurin Mancour, CCRA
Date: Saturday, August 26
Time: 9:00 am – 5:00 pm
Location: Premier Research (1 Park Drive, Research Triangle Park, NC 27709)
**UPDATED EFFECTIVE DATE** The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
