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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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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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HIPAA is a federal law enacted in 1996 by the Department of Health and Human Services that protects patient health information from being used or disclosed without their authorization or knowledge. (Health Insurance Portability and Accountability Act of 1996 (HIPAA) | CDC) HIPAA includes the Privacy Rule and The Security Rule that directly and indirectly impact clinical trials.
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When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.
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Topic for Speaking Engagement and Panel Discussion: Central and Remote Monitoring: Leveraging Central and Remote Monitoring in Risk-Based Quality Management
Topic for Panel Discussion: Medical Device Trial Regulations, Quality and Data Management: Navigating a Changing Regulatory Landscape and Accelerating Approvals
Dates: March 2 - 4, 2021
Location: The virtual summit consists of pre-recorded sessions with live panel discussions and live Q&A sessions.
Register: https://register.healthtech.com/reg/scope
Sandra “SAM” Sather is:
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During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.
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Sponsors outsourcing clinical trials tasks is nothing new, but how does the sponsor ensure CROs and vendors understand which duties or activities they are conducting and how to provide quality services? Regulatory authorities require sponsors to oversee the quality of the work that CROs or vendors working on behalf of the CROs complete. Good oversight means a supportive partnership that should be established and defined early on. Introduction to CRO Oversight lecture video training is now available for purchase in our online store HERE.
