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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).
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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.
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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.
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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.
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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.
What does that mean for the informed consent process for clinical trials?
Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard.
China Food and Drug Administration (CFDA) was accepted as a regulatory member in the International Council for Harmonisation (ICH) whose mission “is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.”
Registration now open!
Certification Exam Prep Course
Presented by: Laurin Mancour, CCRA
Date: Saturday, August 26
Time: 9:00 am – 5:00 pm
Location: Premier Research (1 Park Drive, Research Triangle Park, NC 27709)
**UPDATED EFFECTIVE DATE** The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
Our own SAM Sather will be in the ACRP's Northern California chapter for a discussion of the guideline updates, impact assessment, and a scalable approach to implementation of ICH-GCP E6 R2. For more information click here.
