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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.
The US Department of Health and Human Services along with 15 other agencies published an Interim Final Rule (IFR) in the Federal Register on January 22, 2017. The Interim Final Rule was made available for the public to view on January 17, 2018, and can be found here.
In an effort to improve the user experience, the National Library of Medicine (NLM) released updates to ClinicalTrials.gov on December 18, 2017. ClinicalTrials.gov is a searchable database of publicly and privately funded clinical trials being conducted globally. The information is provided by Sponsors and Investigators, and a listing does not indicate the clinical trial has been evaluated by the United States Federal Government.
What is an Early Feasibility Study?
FDA Announces Least Burdensome Provisions Draft Guidance to Modernize Medical Device Approval.
Background:
CRF Health has released an electronic Clinical Outcome Assessments (eCOA) best resources list of 2017. eCOA uses connected electronic devices to directly report clinical trial outcomes and is utilized by subjects, caregivers, and Investigators. By encouraging timely data entry, eCOA supports the ALCOA principle.
