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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.
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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.
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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
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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.
Key Takeaways:
The Special 510(k) Program is an alternate pathway for premarket notifications.
It was originally established in 1998.
It allows manufacturers to declare that a modification to their own device cleared under 510(k) still conforms to design controls.
Currently, if a manufacturer modifies its own marketed device and changes the indication for use or creates technological differences, the application must be submitted as a traditional 510(k).
A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.
What: First Ever Metrics Champion Consortium (MCC) Summit
Topic: Clinical Trials Risk and Performance Management Summit. Listen to a panel of subject matter experts present current topics such as metrics, centralized monitoring, critical thinking, and issues and risks management. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis.
When: November 14 and 15, 2018
Where: The Westin Princeton at Forrestal Village; Princeton, NJ map
Book the hotel here
Our own Sandra “SAM” Sather is a contributing author for the HIPAA Privacy Rule and FDA Regulated Clinical Trials chapter, which extensively answers questions about protection of privacy during clinical research. The reference guide answers more than 1000 common questions related to US and international Good Clinical Practice (GCP) for clinical trials.
Topic: Contract Research Organization (CRO) oversight after ICH E6(R2)
Date: October 24, 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
Sign up here.
