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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
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The US Food and Drug Administration issued a draft guidance on “Psychedelic Drugs: Considerations for Clinical Investigations” in June 2023. Psychedelics are a new horizon development potential in clinical trials. As more sponsors and sponsor-investigators move towards psychedelic drug development as a new psychiatric therapy, questions arise about the best way to move forward within the regulatory framework for clinical trials.
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The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.
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The U.S. Food and Drug Administration (FDA) announced that the “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” draft guidance is available for comment. When finalized, the draft guidance fulfills the requirement for guidance on decentralized clinical trials under Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA).
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The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft guideline for ICH E6(R3) Good Clinical Practice, which reached step 2 on May 19, 2023 and is open for public consultation. This draft includes the GCP Principles and Annex 1, and updates to Annex 2 of the guideline are now underway.
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The US Food and Drug Administration (FDA) released a draft guidance “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” in March 2023. When finalized, it will replace the 2007 guidance “FDA Computerized Systems Used in Clinical Investigations.” The FDA regulates electronic systems, electronic records, and electronic signatures used by sponsors and CROs to create records required for clinical trials per 21 CFR Part 11.
