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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.
CRO Oversight Post ICH GCP E6 (R2) Addendum: July 18, 2018 Course
Date: July 18, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded
Sign up here.
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a guidance 21st Century Cures Act Guidance: Remote Access to PHI for Activities Preparatory to Research in December 2017 to clarify how protected health information (PHI) may be used via remote electronic access for research preparation activities.
Background:
In Part 1 of our blog series about Food and Drug Administration (FDA)’s draft guidance entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background, and in Part 2 we discussed ethical considerations. Now in Part 3, we will discuss other considerations for enrolling pregnant women in clinical trials.
In Part 1 of our blog series about the Food and Drug Administration (FDA)’s draft guidance on inclusion of pregnant women in clinical trials entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background behind the draft guidance. The FDA identified some risk-based ethical considerations for inclusion of pregnant women, including availability of other treatment options, the type and severity of the disease or condition being treated, and the stage of development of the drug (approved or investigational). The FDA recommends the sponsor consult an ethicist to evaluate the trial design, and the sponsor should have discussions with the FDA, including bioethics and maternal health experts, early in the development stage. In any case, the sponsor must follow the regulations for human subject protections.
The Food and Drug Administration (FDA) published a draft guidance on April 09, 2018 entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry. The public comment period is open until June 08, 2018, and instructions for submissions of comments can be found here.
