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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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Clinical Trial Transformation Initiative (CTTI) collected information from clinical trials stakeholders in March during increasing COVID-19 restrictions. An ongoing concern is how to balance keeping subjects, sites, and monitors safe while deciding whether and how to continue clinical trials or if they should be placed on hold.
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Because of the COVID-19 pandemic, the European Commission announced that the implementation of the Medical Devices Regulation (MDR) will likely be delayed by one year. There are limited resources currently available to implement the MDR by the original date of May 26, 2020.
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Recently, the Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. Clinical trials are facing many challenges due to site closures, travel restrictions, and investigational product supply chain interruptions. The guidance clarifies how to proceed with alternative methods of assessments that maintain subject safety and are in compliance with Good Clinical Practice (GCP), while minimizing risks to data integrity. The FDA just issued an updated document with a Frequently Asked Questions section. The FDA will continue to update the document as new questions arise in the rapidly changing environment of the COVID-19 pandemic.
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Date: April 2, 2020
Time: 1:00 – 2:30 PM EDT
Live or available as recorded session
Register: Here
Background: The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies how to proceed with alternative methods of assessments that maintain subject safety and are in compliance with Good Clinical Practice (GCP), while minimizing risks to data integrity.
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Background:
In the rapidly changing environment of COVID-19 restrictions, how can monitors and investigators ensure subjects and their personal health information remain protected and data remains high-quality? The ongoing challenge of site closures, travel restrictions, and social distancing has many unsure of how to proceed.
