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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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 U.S. Congress reauthorized the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023-2027 on September 30, 2022. PDUFA began in 1992 and must be reauthorized every five years. Starting in 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) included the fifth reauthorization of PDUFA and the third reauthorization of the Medical Device User Fee Act (MDUFA), which began in 2002.
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The U.S. Food and Drug Administration (FDA) released a draft guidance “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers” in November 2022. The regulation governing expanded access went into effect in October 2009, and due to a large volume of questions on how to comply with the regulations, released a guidance documents in June 2016 which was updated in October 2017. After the 2017 guidance, the Agency continued to receive additional questions and changes occurred to the regulation relating to the FDA Reauthorization Act of 2017 (FDARA) and the 21st Century Cures Act (Cures Act).
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Section 3023 of the 21st Century Cures Act (Cures Act) requires harmonizing the human subject protection regulations between U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). In efforts to harmonize with the revised Common Rule, the FDA recently published two proposed rules.
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The US Food and Drug Administration released a final guidance “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products” in September 2022. It describes what needs to be included in the cover letter of a document submission that contains real world evidence or real world data so the Agency can more easily track them.
