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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.
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s April 2018 Expo. The session will cover global regulatory issues and counts as 1.0 ACRP continuing education credits.
Topic: “A Global Perspective on Regulations Impacting Clinical Research”
When: Monday, April 30, 2018 - 3:00 p.m. – 4:00 p.m. EDT
Where: Gaylord National Resort & Convention Center - National Harbor, Maryland (map)
Date: April 23, 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 (available for 30 days)
Testing and completion certificate available
Sign up here
In part 1 of our FDA's Patient-Focused Drug Development blog, we discussed the origin of FDA’s patient-focused drug development from Prescription Drug User Fee Act (PDUFA) V and VI and the 21st Century Cures Act (Cures Act) to the development of a guidance that will allow for the direct collection of patient experience data to guide regulatory decision-making. Plan for Issuance of Patient‐Focused Drug Development Guidance from May 2017 describes FDA’s plan for development of a guidance under the Cures Act.
Date: April 19, 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 (available for 30 days)
Testing and completion certificate available
Sign up here
Background
Improvements in FDA’s benefit-risk analysis and communication began with the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA) V of 2013 (benefit-risk plan, communication plan) (PDUFA V Performance Goals and Procedures), became a priority with PDUFA VI of 2017 (PDUFA VI Performance Goals and Procedures), and expanded with the 21st Century Cures Act (Cures Act) of 2016, which calls for a patient-focused drug development process. Implementation of these Acts can improve FDA’s communication of its drug regulatory decision thought process and incorporate patients’ preferences in drug development and regulatory review.
