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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
Speakers:
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC (Regulatory and Quality, CRF Health)
Elizabeth Weeks-Rowe, LVN, CCRA (Clinical Research Consultant)
Deborah Rosenbaum, CCRA, CCRC, FACRP (President, Sarrison Clinical Research)
Podcast:
Listen to an informative glimpse into the upcoming eConsent webinar with a podcast available here.
Join us Thursday March 8th as Deborah, Elizabeth and SAM discuss the benefits of integrating eConsent into your consenting process as well as the benefits it has on monitoring and data integrity. Sponsors have the responsibility of ensuring all subjects have been properly consented and which requires onsite visits from the sponsor’s monitor to manage the informed consent process. These 3 are experts in informed consent and have decades of monitoring experience between them and will speak on the advantages of eConsent from their own personal experiences as well as the challenges they have encountered throughout the years.
The US Department of Health and Human Services along with 15 other agencies published an Interim Final Rule (IFR) in the Federal Register on January 22, 2017. The Interim Final Rule was made available for the public to view on January 17, 2018, and can be found here.
