-
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).
-
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.
-
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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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.
-
“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.
-
A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
-
Metrics Champion Consortium (MCC) launched the work group last October as an opportunity for MCC member organizations to discuss how risk-based quality management is transforming process metrics for monitoring. The work group is considering the impacts that centralized, targeted, and remote monitoring have on process metrics, which have traditionally been based on onsite monitoring.
-
There have been many questions about how to monitor clinical trials amid the changing landscape of COVID-19 restrictions. Remote monitoring is one of the ways of reducing onsite monitoring visits at a time of physical distancing and travel restrictions. Metrics Champion Consortium (MCC) launched the MCC COVID-19 Knowledge Sharing Group as an opportunity for MCC member organizations to share knowledge and to support one another during this uncertain time.
-
Our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar prompted many important questions, which we answered during the webinars. If you missed the webinar, a recording is now available for purchase. We also compiled a FAQ document to help guide your remote monitoring efforts during the crisis.
-
Clinical Trial Transformation Initiative (CTTI) collected information from clinical trials stakeholders in March during increasing COVID-19 restrictions. An ongoing concern is how to balance keeping subjects, sites, and monitors safe while deciding whether and how to continue clinical trials or if they should be placed on hold.
-
Because of the COVID-19 pandemic, the European Commission announced that the implementation of the Medical Devices Regulation (MDR) will likely be delayed by one year. There are limited resources currently available to implement the MDR by the original date of May 26, 2020.
