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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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The US Food and Drug Administration (FDA) released a draft guidance “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” for public comment in October 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Comment now through January 21, 2022 HERE.
What does ‘T’ stand for?
Everyone talks about learning from when things go wrong. People say it's the best way to learn, but it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?
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Date: 27 January 2022
Time: 10:30 AM - 12:00 PM EST
Location: Interactive Webinar
Registration: HERE
Training on RCA does not usually happen, so many do not know how to carry out a proper RCA. Yet, it is an important step in understanding what happened so the issue(s) can be prevented from recurring. In this webinar, you will learn about a practical approach to RCA that shows results while encouraging critical thinking for GXP professionals.
These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change. Attendance at this or another session (live or recorded) is required before attending the Train-the-Trainer workshop scheduled for February 15 & 22.
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There are two recent warning letters relating to sponsor-investigators. (warning letter 1 HERE and warning letter 2 HERE). A sponsor-investigator both initiates and conducts a clinical trial, which is also known as an investigator initiated clinical trial (IIT). In both examples, the investigator used protocols internal to the institution but did not submit an Investigational New Drug (IND) application to the FDA. The drugs chosen for the protocols were approved and being used for on label use in the protocols. However, the protocols restricted what drug was being used and so could not be considered standard of care.
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The US Food and Drug Administration (FDA) wrote a letter to industry, “Studies Using Leftover, Deidentified Human Specimens Require IRB Review.” It is a reminder to in vitro diagnostic medical device sponsors that Institutional Review Board (IRB) review is needed for clinical trials on leftover, de-identified human specimens. The 2006 FDA guidance “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” clarifies that informed consent to use leftover human specimens that are not individually identifiable is not required, if it meets exemption criteria from the Investigational Device Exemptions (IDE) regulation (21 CFR 812.2(c)(3)).
