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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
Since March 29th 2017 when the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), the clinical research industry has been wondering about the implications of this unprecedented withdrawal particularly since the European Commission and EMA believe that the UK will no longer participate in the EMA’s work after March 30th of 2019.
Date: May 15, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
Description:
Pediatric clinical trials present unique challenges since minors, as a vulnerable population, require a variety of regulatory protections to be incorporated as part of the study’s design, recruitment strategies, and monitoring plan.
Date: April 20, 2017
Time: 11:00 am EST | 15:00 GMT
Join us and CRF Health on this upcoming webinar hosted by Xtalks. We'll discuss the following benchmarks from the State of eConsent 2017 Report: https://attendee.gotowebinar.com/register/5600985180645861634
“Q: If local policy differs from the region’s regulations pertaining to the conduct of a clinical trial at a research site, what should be followed? A: The strictest requirements”. In response to this question one may ask, where can I find the local regulations for my study? A situation compounded in multinational trials. A helpful tool to reference is the OHRP’s International Compilation of Human Research Standards which was first published on 2005.
