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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: April 23, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Testing and completion certificate available
Sign up here
In part 1 of our FDA's Patient-Focused Drug Development blog, we discussed the origin of FDA’s patient-focused drug development from Prescription Drug User Fee Act (PDUFA) V and VI and the 21st Century Cures Act (Cures Act) to the development of a guidance that will allow for the direct collection of patient experience data to guide regulatory decision-making. Plan for Issuance of Patient‐Focused Drug Development Guidance from May 2017 describes FDA’s plan for development of a guidance under the Cures Act.
Date: April 19, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
Testing and completion certificate available
Sign up here
Background
Improvements in FDA’s benefit-risk analysis and communication began with the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA) V of 2013 (benefit-risk plan, communication plan) (PDUFA V Performance Goals and Procedures), became a priority with PDUFA VI of 2017 (PDUFA VI Performance Goals and Procedures), and expanded with the 21st Century Cures Act (Cures Act) of 2016, which calls for a patient-focused drug development process. Implementation of these Acts can improve FDA’s communication of its drug regulatory decision thought process and incorporate patients’ preferences in drug development and regulatory review.
In response to questions about travel reimbursements, the Food and Drug Administration’s (FDA) Office of Good Clinical Practice published an updated Information Sheet on January 25, 2018, retitled “Payment and Reimbursement to Research Subjects” to reflect the clarifications. Stakeholders for this guidance are Institutional Review Boards (IRB) and Investigators.
