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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
The Food and Drug Administration (FDA) published a draft guidance on April 09, 2018 entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry. The public comment period is open until June 08, 2018, and instructions for submissions of comments can be found here.
In Part 1 of our blog, we discussed the introduction, background, and policy for the US Food and Drug Administration (FDA) draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. We will continue Part 2 of our blog with appropriate use of the Expanded Abbreviated 510(k) pathway, FDA’s identification of performance criteria, and data submission to the FDA.
The US Food and Drug Administration (FDA) released a draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria on April 12, 2018. The comment period is open through July 11, 2018, and directions for comment submissions can be found here.
Date: June 4, 2018
Time: 1:00 p.m. – 2:30 p.m. EDT
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session and recorded (available for 30 days)
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Co-authored by our own Sandra SAM Sather, MS, BSN, RN, CCRC, CCRA and Julie Blasingim, MBA, CIP, “An IRB Perspective on Improving Informed Consent” was published in the April 2018 issue of the Association of Clinical Research Professionals’ (ACRP’s) peer-reviewed journal, Clinical Researcher.
