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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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The Food and Drug Administration (FDA) has released a draft guidance, “Rare Diseases: Natural History Studies for Drug Development”. We discussed another draft guidance released in January, “Rare Diseases: Common Issues in Drug Development” in our blog. The new draft guidance describes how natural history studies may be best used for drug development for rare diseases.
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What does ‘I’ stand for?
You have probably heard of the Five Whys approach to getting to root cause. ‘Why’ is a good question to ask - but not until you've dug around for more information first. After all, you are soon to find additional questions, such as: When did the problem start? - and - Where exactly is the problem? The ‘I’ step in the DIGR-ACT® solution helps through ‘Is - Is Not’ questions. They can help lead you to define the issue better but may also point you in the direction of the root causes.
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We are excited to announce that eLearning courses are now available for purchase in our Clinical Pathways store, with more courses coming soon! All courses are available at a special introductory rate through April 30th.
One of our key eLearning courses is our Good Clinical Practice (GCP) training, updated with the latest from ICH E6 (R2) Addendum.
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Now that Brexit has been delayed, there is still no guarantee of a deal. The extension will be until April 12 if the withdrawal agreement is not approved by the UK House of Commons by March 29, and until May 22 if it is. During this time, the UK will continue to be a Member State in the EU. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are preparing for the possibility of a no deal Brexit.
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The Food and Drug Administration released a new draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry”. The purpose of the guidance is to provide additional clarification to the finalized Risk Based Monitoring (RBM) guidance from 2013. Questions and answers provide details about:
