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EU Commission Releases Draft Annex 11: ...

12/02/2025

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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.

EU Commission Releases Draft Annex 11: Computerised Systems
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Warning Letter Issued to Investigator of ...

11/18/2025

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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.

Warning Letter Issued to Investigator of Pediatric Study
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ISO Release DIS 9001:2026 for Quality ...

11/06/2025

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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.

ISO Release DIS 9001:2026 for Quality Management Systems
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Problems Found in Sponsor-Investigator Led Trial

10/30/2025

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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.

Problems Found in Sponsor-Investigator Led Trial
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Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

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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.

Sponsor BIMO Warning Letter – What is a Drug?

FDA FINAL Guidance for Electronic Health Record Data Released!

7/24/2018

The Food and Drug Administration (FDA) published a guidance document on July 18, 2018, entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry,” which finalizes the draft guidance released in May 2016. The purpose of the guidance is to support industry in use of electronic data capture systems (EDC) and electronic health records (EHR) while protecting the confidentiality, integrity, and security of data. The guidance aligns with the 21st Century Cures Act, which prompted the FDA to publish guidance for use of “real-world evidence” in regulatory activities.

Remote Access to PHI

7/13/2018

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:

  • The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule found in 45 CFR Part 160 and Subparts A and E of Part 164 describe how PHI may be used for research by a covered entity.

FDA Drafts Guidance for Consideration for Inclusion of Pregnant Women in Clinical Trials – Part 3

6/9/2018

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.