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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

What Quality System Requirements are Needed for Medical Device Cybersecurity? New FDA Draft Guidance

04/19/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” for comment in April 2022. The draft guidance, when finalized, will modernize premarket expectations for medical devices with advanced connection technologies that may pose a cybersecurity risk. The draft guidance also describes cybersecurity medical design, labeling, and recommended documentation to be included in premarket submissions for devices with a cybersecurity risk.

FDA Releases Guidance: Overview of ICH E8(R1): General Considerations for Clinical Studies

04/12/2022

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Clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. ICH E8(R1) is intended to address the concerns about the principles of trial design and planning that are needed to ensure an appropriate level of data quality.

EU Advice to Sponsors for Trials Impacted by Ukraine War

04/05/2022

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The European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) issued advice to sponsors on how to manage clinical trials that are impacted by the Russian invasion of Ukraine. Sponsors requested advice on how to manage protocol deviations, source documents, missing data, and other changes that are due to the ongoing Ukrainian war.

MDUFA V Proposed Recommendations for Reauthorization Ready for Public Meeting

03/29/2022

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The US Food and Drug Administration (FDA) published a press release confirming that the FDA and medical device industry stakeholders reached an agreement on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Amendments of 2023 (MDUFA V). The first authorized user fee for medical device occurred with the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Which Regulatory Pathway for Combination Products? New Final Guidance Clarifies

03/22/2022

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The US Food and Drug Administration (FDA) released a final guidance, “Principles of Premarket Pathways for Combination Products” in January 2022. Section 3038 of the 21st Century Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding combination products. This included requirements for consistent premarket regulatory expectations and aligned premarket review for combination products. The guidance describes principles for premarket review of combination products in line with the amendments implemented by the Cures Act.