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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
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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.
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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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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.
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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.
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What does ‘A’ stand for?
Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.
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Dates: Two part series – Online live attendance mandatory
19 Oct 2021, 10:00 AM 1:00 PM (EDT)
AND
26 Oct 2021, 10:00 AM 1:00 PM (EDT)
Location: Live online
Registration: HERE
DIGR-ACT® is a process for you to integrate into your operations to better support critical to quality factors and your quality system in a rapidly changing environment. Better handling and prevention of issues that matter means better project outcomes and less tears!
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The US Food and Drug Administration (FDA) released an updated guidance, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”. As clinical research professionals navigate the long haul new normal, many are wondering if the remote monitoring that occurred during the pandemic shutdowns was adequate to meet regulatory requirements. The FDA continued to update the guidance as new questions arose. The new question added to the Questions and Answers section of the guidance is:
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What does ‘R’ stand for?
We're all in a rush, and we want to fix issues quickly. But often, by assuming too much, we might reach the wrong conclusion. The cause that we used root cause analysis tools to discover is actually incorrect. Once we have the (wrong) cause(s), we may rush off and take action to fix it. But if it's the wrong cause, it is wasted effort and you rushed - only to go slow. Like if your taxi doesn't show, you might decide never to use that company again because they are unreliable - when the real problem was that you gave them the wrong pick-up address.
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The US Food and Drug Administration (FDA) is holding a public meeting to discuss recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA). Stakeholders are invited to discuss their opinions on recommended enhancements for the next reauthorization. PDUFA began in 1992 and must be reauthorized every five years.
