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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.
We are excited to announce SAM Sather’s contribution to the newly released CenterWatch resource "The CRC’s Guide to Coordinating Clinical Research”. SAM has worked within the clinical trial and healthcare industry for around 30 years as a nurse, study coordinator, monitor, auditor, trainer and more. SAM expressed gratitude to CenterWatch for allowing her toupdate the book.
An FDA warning letter was issued to John D. Gabriel, M.D. relating to “objectionable conditions observed during” the course of the inspection conducted at his clinical site between February 1 and 18, 2016. This letter highlights the importance of staying informed and collecting detailed medical histories for subjects enrolled in the clinical study before any tests are carried out. The Form FDA 483 outlines the investigator’s negligence to adhere to the investigation plan outlined in the protocol thereby failing to ensure subject safety during the clinical trial.
