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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
What is the GDPR?
The European Union’s (EU) General Data Protection Regulation (GDPR) goes into effect on May 25, 2018. The purpose of the GDPR is to protect the privacy and security of personal data and to strengthen the accountability to those using personal data.
Background
Women were underrepresented at under 20% of subjects in clinical trials in the 1990s.
The Food and Drug Administration (FDA)’s Office of Women’s Health (OWH) was formed in 1994 with a mission to ensure adequate involvement of women in clinical trials and to identify specific requirements and challenges for women’s health.
Clinical Trials Day recognizes clinical trials professionals’ contributions to the advancement of medicine and public health. It is celebrated yearly on May 20th globally in remembrance of what is believed to be the first randomized clinical trial. During a time when scurvy killed many at sea, James Lind, the surgeon aboard the HMS Salisbury of Britain’s Royal Navy, devised a “study” involving 12 men given one of six different treatments in May 1747. Those who were given citrus showed improvement. This is regarded as the beginning of clinical trial design.
There are concerns over how the United Kingdom’s (UK) departure from the European Union (EU), also known as Brexit, will affect clinical research stakeholders in the UK and the EU. Brexit will begin March 29, 2019. Since the European Medicines Agency (EMA) is a EU Agency, would that mean that the UK would no longer be a part of the Agency or follow the regulations set by it? What effects would the change have on harmonization of clinical trials through Europe and globally?
How does Brexit affect the EMA headquarters, and will it remain independent?
