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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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 purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.
The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.
TransCelerate Biopharma Inc. has released a set of eConsent Assets as part of its eConsent Initiative.
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at ACRP: Research Triangle Park Chapter’s 18th Annual Fall Conference on Friday, November 10, 2017.
Topic: “Perspectives in Clinical Research"
When: Thursday, November 9 – Friday, November 10, 2017
Where: North Carolina Biotechnology Center (map)
Meeting: “Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH).”
The Food and Drug Association (FDA) and Health Canada will be holding a Joint Public Consultation meeting.
