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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
We are excited to announce SAM Sather’s contribution to the newly released CenterWatch resource "The CRC’s Guide to Coordinating Clinical Research”. SAM has worked within the clinical trial and healthcare industry for around 30 years as a nurse, study coordinator, monitor, auditor, trainer and more. SAM expressed gratitude to CenterWatch for allowing her toupdate the book.
An FDA warning letter was issued to John D. Gabriel, M.D. relating to “objectionable conditions observed during” the course of the inspection conducted at his clinical site between February 1 and 18, 2016. This letter highlights the importance of staying informed and collecting detailed medical histories for subjects enrolled in the clinical study before any tests are carried out. The Form FDA 483 outlines the investigator’s negligence to adhere to the investigation plan outlined in the protocol thereby failing to ensure subject safety during the clinical trial.
Date: October 13, 2016
Time: 11:00 am EST | 15:00 GMT
Link: http://tinyurl.com/econsentwebinar
Our own SAM Sather and Mika Lindroos from CRF Health will discuss the important topic of regulatory risks in the informed consent process on this exciting upcoming webinar. As you know, Informed Consent is one of the most cited GCP deficiencies by regulatory authorities and contributes to increases in the risk of delayed approvals, litigation and yes, even trial failure.
