-
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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
-
Due to the global pandemic, the Food and Drug Administration (FDA) temporarily stopped onsite inspections in March. In the interim, they have been conducting remote assessments following a risk-based approach. The FDA is planning to resume onsite domestic inspections the week of July 20th. During the reopening, the health and safety of all involved will be a priority, and any regional restrictions will be followed.
-
Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.
-
With clinical trial sites prolonging restricted access and sponsor or CRO monitors continuing to monitor clinical trials remotely, more clarification of how to proceed in the current environment while maintaining subject safety and data integrity and quality is needed. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on methods of obtaining informed consent from patients in isolation and an additional question and answer.
-
Have you ever heard or stated, “We are not doing risk-based monitoring for this study”? This is using the term to refer to a style vs. a process to conduct monitoring based on risk. This means that there was a decision to conduct “traditional” monitoring, with 100 percent source data verification (SDV) and/or 100 percent data review of trial subjects.
-
Originally released in March 2020, the Food and Drug Administration (FDA) revised their “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” in June 2020. The guidance is applicable for the duration of the current pandemic. It is intended to further clarify how already marketed non-invasive medical devices may be used with COVID-19 patients to reduce transmission.
