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New Final Guidance Q&A on RRAs

07/08/2025

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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.

New Final Guidance Q&A on RRAs
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BIMO Finds Objectionable Conditions During ...

06/23/2025

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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”.

BIMO Finds Objectionable Conditions During Inspection
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FDA shares FAQs on IRBs

06/17/2025

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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.

FDA shares FAQs on IRBs
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Final Guidance Released on IRB Written ...

06/03/2025

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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.”

Final Guidance Released on IRB Written Procedures
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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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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.

Bioresearch Monitoring Program

BIMO Finds Objectionable Conditions During Inspection

BIMO Finds Objectionable Conditions During Inspection

06/23/2025

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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”.

FDA BIMO Inspection Results in Warning Letter

FDA BIMO Inspection Results in Warning Letter

02/19/2025

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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).

FDA Issues Warning Letter for Clinical Investigation Violations

01/03/2024

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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.