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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

FDA Framework for Use of Real-World Evidence

11/05/2019

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The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.

CTTI Releases Recommendations for Real-World Data in Study Planning and Recruitment

10/22/2019

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Clinical Trials Transformation Initiative (CTTI) released recommendations and tools related to using real-world data (RWD) to inform selecting eligibility criteria and recruitment of subjects for clinical trials. RWD are data related to patient health and health care delivery. Data are commonly collected from Electronic Heath Records (EHR) or other sources related to patient health, such as insurance claims. RWD has been available, but there has been a lack of research or consensus on how to use the information beneficially for clinical trials. These recommendations were developed through research and collaboration with stakeholders, including patients and caregivers, to provide the first steps for how sponsors may best use the RWD to plan for clinical trial eligibility requirements and recruitment.

FDA Releases Draft Guidance on Device Clinical Trials and Patient Engagement: Comment Now!

10/15/2019

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The US Food and Drug Administration (FDA) released a draft guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The purpose is to guide industry in accounting for patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives. The draft guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials. The idea is that patients must be willing and able to use a medical device in order for it to have a practical benefit, so understanding any potential barriers prior to conducting a clinical trial would be beneficial.