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FDA BIMO Inspection Results in Warning Letter

02/19/2025

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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).

FDA BIMO Inspection Results in Warning Letter
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The Fourth Edition of ISO 14155 Coming Soon

02/04/2025

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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO

The Fourth Edition of ISO 14155 Coming Soon
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New GCP Book Coauthored by Clinical Pathways ...

01/29/2025

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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.

New GCP Book Coauthored by Clinical Pathways Now Available
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New Draft Guidance on Protocol Deviation ...

01/21/2025

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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).

ICH E6(R3) Progresses into Step Four

device software

Computer Modeling and Simulations for Device Regulatory Submissions Draft Guidance

01/11/2022

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The US Food and Drug Administration (FDA) released a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” late December 2021. The draft guidance provides a framework for assessing if software modeling used to support medical device premarket submissions are credible. Regulatory submissions often lack adequate explanation of the rationale for the models’ credibility for the context of use (COU). The COU is the specific role and scope of the model used to address the “question of interest.”

Device Software Functions Draft Guidance: Comment Now!

01/04/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Content of Premarket Submissions for Device Software Functions.” The draft guidance clarifies documentation that is needed for a premarket submission for device software functions. The 21st Century Cures Act excluded certain software functions from the definition of device (see the guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”). The draft guidance addresses these changes as well as the evolution of digital health and the recent FDA recognized consensus standards for software, which are standards that the FDA determines can support clearance or approval of a device.