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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.
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Have you visited the European Medicines Agency’s (EMA) Frequently Asked Questions (FAQ) page? It is a valuable resource for sponsors and CROs participating in global trials in reference to Good Clinical Practice (GCP) in the context of the 28 countries of the European Union.
On this site, the EMA has published answers to the most frequently asked questions it has received and organized them into 11 categories.
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During the current COVID-19 pandemic, it has become necessary for sponsors of clinical trials to rely on remote methods to access electronic health records and electronic source data. With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data. Here is one such question.
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As sponsor or CRO monitors are continuing to monitor clinical trial sites remotely for the foreseeable future, additional clarification is needed for how to proceed while protecting subject safety and data integrity. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on the requirements for the investigator to review IND safety reports. The question and answer guidance shows how we must be very careful to not decrease the safety protection checks and balances we have in GCP between stakeholders.
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Sandra “SAM” Sather will be speaking at the Society of Quality Assurance (SQA) September Virtual Meeting and Quality College on the topics:
Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19
Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19
When: September 21 and 22, 2020
Where: Virtual
Schedule: HERE
Register: HERE
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When: September 17, 2020
Time: Live from 1-2 PM EDT
Register: HERE
Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry.
