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The Health Research Authority (HRA) announced that England and Wales have begun implementing changes to their clinical trial regulations on June 1st, 2024. These changes include the removal of the requirement for trials to submit annual progress report to their Research Ethics Committee (REC) and the process of submitting safety reports. Scotland and Northern Ireland, following review, also implemented these changes to their regulations making the updates now applicable in all four of the UK nations as of August 1st, 2024.
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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.
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In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems.
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In September 2024, the Food and Drug Administration (FDA) released another draft guidance titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” for sponsors intending to conduct global clinical development programs (CDP) for new cancer treatments. The guidance provides advice on using evidence obtained from multi-regional clinical trials (MRCT) to support marketing applications.
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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits
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The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDER) announced that they have opened for all pre-submissions. During the pandemic, CDRH prioritized Emergency Use Authorization (EUA) for devices specifically related to the pandemic. In that same time, they also
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Clinical Pathways has exciting news to share about Biopharma Institute, a trusted partner and reseller for our catalog of eLearning courses. They were featured in Life Sciences Review as a Top 10 Emerging Clinical Trial Management Company of 2022, with an exclusive interview with Sandra “Sam” Sather, VP at Clinical Pathways.
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The US Food and Drug Administration (FDA) released a guidance “Refuse to Accept Policy for 510(k)s” in April 2022. This guidance was originally issued in May 1994 and was previously updated in September 2019. The guidance describes the procedures the FDA uses to determine if a medical device premarket notification (510(k)) meets the minimum threshold of acceptability for their regulatory review.
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The US Food and Drug Administration (FDA) released a draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” for comment in April 2022. The draft guidance, when finalized, will modernize premarket expectations for medical devices with advanced connection technologies that may pose a cybersecurity risk. The draft guidance also describes cybersecurity medical design, labeling, and recommended documentation to be included in premarket submissions for devices with a cybersecurity risk.
