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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.

IRB Warning Letter from BIMO Inspection
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FDA Webinar on Improving the Informed Consent ...

02/26/2025

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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.

FDA Webinar on Improving the Informed Consent Process

Comment Now! FDA Releases Combination Product Draft Guidance

1/15/2020

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The U.S. Food and Drug Administration (FDA) released a draft guidance “Requesting FDA Feedback on Combination Products” for comment. Combination products are made of a combination of two or more components that are drug, biologic, and/or device. They can be 1) components of one entity, 2) packaged together (such as a kit), or 3) packaged separately but intended to be used together. The purpose of the draft guidance is to clarify how the combination product sponsor can request feedback on regulatory questions and to describe best practices for communication with the FDA.

Clinical Study Reports eLearning Course Now Available for Purchase!

1/06/2020

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What is ICH E3 and why is it important?

ICH E3 is one of the ICH technical Guidelines related to clinical trials to promote harmonization globally. The purpose of the Guidance is to harmonize clinical study reports (CSR) across all regulatory authorities. ICH E3 provides guidance for the sponsor for what needs to be included in the CSR and to develop a CSR that is complete, specific, well-organized, and easy for those receiving the CSR to review.

Guidance on Adaptive Design for Clinical Trials Released for Comments!

12/04/2019

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The Food and Drug Administration (FDA) released a final guidance “Adaptive Designs for Clinical Trials of Drugs and Biologics” for comments. An adaptive designed clinical trial means that during the trial, the design can be changed based on an interim analysis of the data collected from subjects already enrolled. This means that the trial design could be altered during enrollment to increase the type of subjects that are more likely to benefit or reduce those who may be at greater risk for adverse effect. This could reduce the time needed to determine if the investigational product is safe and effective and reduce risks to subjects. The final guidance clarifies principles for the design, conduct, and reporting of adaptive clinical trials for evaluation of safety and effectiveness of drugs and biologics and is part of FDA’s modernization efforts.

Clinical Safety Data Management eLearning Course Now Available for Purchase!

11/21/2019

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What is ICH E2A? ICH E2A provides guidance on how to handle expedited safety reporting and includes important definitions and standards. Following harmonized standards and procedures for safety reporting on investigational products ensures Good Clinical Practice (GCP).

Critical Thinking and Artificial Intelligence

11/14/2019

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In the ever-evolving world of increasing automation, computers and artificial intelligence are taking over jobs that humans use to do. Self-driving cars and home assistant devices may be helpful, but humans are still necessary for their critical thinking skills that artificial intelligence cannot replace.