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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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 European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) issued advice to sponsors on how to manage clinical trials that are impacted by the Russian invasion of Ukraine. Sponsors requested advice on how to manage protocol deviations, source documents, missing data, and other changes that are due to the ongoing Ukrainian war.
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The US Food and Drug Administration (FDA) published a press release confirming that the FDA and medical device industry stakeholders reached an agreement on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Amendments of 2023 (MDUFA V). The first authorized user fee for medical device occurred with the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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The US Food and Drug Administration (FDA) released a final guidance, “Principles of Premarket Pathways for Combination Products” in January 2022. Section 3038 of the 21st Century Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding combination products. This included requirements for consistent premarket regulatory expectations and aligned premarket review for combination products. The guidance describes principles for premarket review of combination products in line with the amendments implemented by the Cures Act.
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In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.
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The Food and Drug Administration (FDA) released a guidance “Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Clinical Evaluation” in January 2022. This and a related guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” from December 2009 are part of an initiative by the Center for Devices and Radiological Health (CDRH) to incorporate the use of patient-reported outcomes (PROs) in evaluating medical devices. The guidance does not replace the Patient-Focused Drug Development (PFDD) guidance series.
