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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.
The US Food and Drug Administration (FDA) released a draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria on April 12, 2018. The comment period is open through July 11, 2018, and directions for comment submissions can be found here.
Date: June 4, 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
Co-authored by our own Sandra SAM Sather, MS, BSN, RN, CCRC, CCRA and Julie Blasingim, MBA, CIP, “An IRB Perspective on Improving Informed Consent” was published in the April 2018 issue of the Association of Clinical Research Professionals’ (ACRP’s) peer-reviewed journal, Clinical Researcher.
What is the GDPR?
The European Union’s (EU) General Data Protection Regulation (GDPR) goes into effect on May 25, 2018. The purpose of the GDPR is to protect the privacy and security of personal data and to strengthen the accountability to those using personal data.
Background
Women were underrepresented at under 20% of subjects in clinical trials in the 1990s.
The Food and Drug Administration (FDA)’s Office of Women’s Health (OWH) was formed in 1994 with a mission to ensure adequate involvement of women in clinical trials and to identify specific requirements and challenges for women’s health.
