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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.
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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.
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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.
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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”
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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
Date: October 13, 2016
Time: 11:00 am EST | 15:00 GMT
Link: http://tinyurl.com/econsentwebinar
Our own SAM Sather and Mika Lindroos from CRF Health will discuss the important topic of regulatory risks in the informed consent process on this exciting upcoming webinar. As you know, Informed Consent is one of the most cited GCP deficiencies by regulatory authorities and contributes to increases in the risk of delayed approvals, litigation and yes, even trial failure.
According to the Office for Human Research Protections, the Common Rule, which began circulating in 1991, is undergoing an upgrade of sorts in order to ensure the better protection of human subjects involved in research conducted through clinical trials. The U.S. Department of Health and Human Services has propositioned the revision of the Federal Policy for the Protection of Human Subjects. The goal of the Common Rule’s revision would be to strengthen the overall policy through modernization and an increase and focus on efficiency.
Date: June 16, 2016
Time: 1:00pm-2:30pm, EDT US
Duration: 90 Minutes - Online
Course Link: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001
UPDATE: This course will include discussion of the NEW FDA Draft Guidance “Use of Electronic Health Record (EHR) data in Clinical Investigations”
June 14th, 2016, TOMORROW
11:00 am EDT | 16:00 GMT
Key processes within our industry have been in need of substantial change and improvement, one being the informed consent process.
Informed consent is still one of the most cited regulatory deficiencies, this along with the new technologies available will make electronic consent more and more commonplace. Facing this new reality, we must learn how this impacts each stakeholder.
An FDA warning letter issued by Director David Burrow, Pharm.D., J.D. of the U.S. Food and Drug Administration to Benedict S. Liao, M.D. informs Dr. Benedict of the “objectionable conditions observed during” the course of an FDA inspection conducted at his clinical site between August 11 and September 29, 2015. This letter is a great example of the importance of having proper investigator training on research and the study protocol. Many of the findings outlined in the Form FDA 483 can be traced back to the investigator’s brazen disregard for the protocol and lack of understanding of the difference between standard of care and clinical research, as seen in his written response:
