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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.
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Why Take a Course in The General Data Protection Regulation (GDPR) and Clinical Trials?
Clinical trials are increasingly global by nature. The GDPR may apply to your clinical trial if conducted in a country within the European Economic Area (EEA) or the United Kingdom (UK). The GDPR data protections are broad in nature but it makes it clear that protection of personal data includes data created during the course of a clinical trial. Understanding the role your organization plays, which data are personal, and what constitutes a valid consent under GDPR requirements is key to compliance. This course highlights how HIPAA differs from GDPR, including reporting of data breach and notice requirements.
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Diversity in clinical research is imperative to ensure the safety and effectiveness of drugs and medical devices for all people. Participants in clinical trials should reflect the consumers that will be using the medical product once it is approved. This is a concern because the product may react differently in different age groups, races, and ethnicities. The National Institutes of Health (NIH) confronted a lack of diversity in clinical trial participants in 1993 by supporting a policy requiring federally funded clinical research to include women and minorities called the NIH Revitalization Act of 1993. Clinical trials today still lack ethnic diversity, and the question remains as to how stakeholders can build equity into clinical trial design.
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On October 1, a man from Richland, Washington was pronounced guilty of 47 counts of fraud and drug-related charges. Sami Anwar faces more than 28 years in federal prison according to the U.S. Justice Department’s Eastern District of Washington.
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The Food and Drug Administration (FDA) released a final guidance in November 2020, “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs.” Certain populations are underrepresented in clinical trials, even though they are part of the target audience for the investigational product once approved. The guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).
