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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
Background:
The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” specifies the requirements for the protection of human subjects in U.S. Department of Health and Human Services (HHS) sponsored clinical trials. A final rule published to the Federal Register in January 2017 revised the Common Rule, which has a compliance date of January 21, 2019.
The Center for Biologics Evaluation and Research’s (CBER) Bioresearch Monitoring Program released a new investigator Warning Letter October, 2018. Interestingly, the category is listed as IRB. The investigator was involved with a clinical study of influenza vaccination in the pediatric population.
Background:
Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.
Join with subject matter experts and learn what really matters in clinical trial performance metrics in the first ever Metrics Champion Consortium (MCC) Summit. Our own Sandra “SAM” Sather will present the topics critical thinking and root cause analysis. Understand if your staff has adequate critical thinking skills to evaluate risk and take appropriate action. Identify effective performance management using Gilbert’s Behavioral Engineering Model (BEM) in Clinical Research. Discover answers to key questions while delving into case scenarios with speakers and other attendees during the interactive session.
