IRB

FDA shares FAQs on IRBs

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.

Final Guidance Released on IRB Written Procedures

Final Guidance Released on IRB Written Procedures

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.”

IRB Warning Letter from BIMO Inspection

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.

FDA Issues Warning Letter to IRB Following BIMO Inspection

04/23/2024

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On March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings.

FDA Publishes Proposed Rules in Effort to Harmonize with the Revised Common Rule

11/03/2022

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Section 3023 of the 21st Century Cures Act (Cures Act) requires harmonizing the human subject protection regulations between U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). In efforts to harmonize with the revised Common Rule, the FDA recently published two proposed rules.