Sandra Sather
FDA Releases Final Guidance on Decentralized ...

11/18/2024

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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).

FDA Releases Final Guidance on Decentralized Clinical Trials
Sandra Sather
FDA Issues Warning Letter Regarding Patient ...

10/22/2024

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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.

FDA Issues Warning Letter Regarding Patient Overdose
Guest User
FDA Updates Guidance to Address the Spread of ...

10/10/2024

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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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.

FDA Updates Guidance to Address the Spread of Misinformation
Sandra Sather
Real-World Data and Evidence Generation with ...

10/01/2024

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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.

Real-World Data and Evidence Generation with Dr. Hilary Marston
Sandra Sather
New Draft Guidance on Predetermined Change ...

09/18/2024

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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.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices

Risk Based Monitoring Q&A Guidance

04/25/2023

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The US Food and Drug Administration (FDA) released a final questions and answers guidance document, “A Risk-Based Approach to Monitoring of Clinical Investigations” in April 2023. It includes recommendations for developing a monitoring approach and the content of the monitoring plan, and follow up and communication of the monitoring results. The questions and answers guidance is a companion to the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” guidance from August 2013.

Sponsor Oversight of Decentralized Clinical Trials

04/11/2023

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Decentralized clinical trials (DCTs) have increased in popularity during the pandemic. The US Food and Drug Administration (FDA) released guidance on Conduct of Clinical Trails of Medical Products During the COVID-19 Public Health Emergency that clarified that decentralization of clinical trials through remote collection of data outside of a physical location is permissible as long as methods follow regulatory requirements.

IRB Receives FDA Warning Letter

03/28/2023

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Recently, a community hospital Institutional Review Board (IRB) received a US Food and Drug Administration (FDA) warning letter for lack of appropriate members present to review research, inadequate documentation, and inadequate informed consent review.