Welcome to our monthly newsletter: your place for the latest industry and regulatory news in the world of Pharmacovigilance and AI!
FDA's approach to responsible AI in healthcare
The Food and Drug Administration’s (FDA’s) blog "The Promise Artificial Intelligence Holds for Improving Health Care" highlights AI's transformative potential to improve patient care, accelerate medical research, and enhance operational efficiency in the healthcare field. This article focuses on ways to foster responsible AI innovations, and how to seek alignment within the ecosystem around AI in healthcare. This includes reducing risk via an AI Development Lifecycle Framework and developing a robust quality assurance practice for AI models. These concepts include: a) Standards, best practices and operational tools, b) Quality assurance laboratories, c) Transparency and accountability, and d) Risk management for AI models. The FDA's efforts intend to balance innovation with patient safety, ultimately helping to improve healthcare outcomes.
The FDA's blog aligns with our approach at biologit, emphasising transparency, accountability, and risk management. When it comes to quality, compliance, and security, we hold ourselves accountable to the highest standards. For more information on how we incorporate these principles, visit our website: Security, Compliance and Quality | Biologit
For more information, about the blog visit the FDA's website on Blog: The Promise Artificial Intelligence Holds for Improving Health Care | FDA
Unearthing Crucial Safety Events: Why Local Literature Matters in Pharmacovigilance
Local journals provide valuable insights for understanding the safety profile of your drugs, but
searching can be complex and time-consuming. The biologit Platform allows users to overcome many challenges associated with local literature monitoring.
In this recent case study, our Product Manager, Naveen Basar conducts a broad literature search that highlights the importance of searching local sources in identifying ICSRs, and the benefits of using the biologit Platform.
Here we present findings for methimazole, a thionamide anti-thyroid agent used to treat hyperthyroidism which has been authorised in many markets around the world. In this search, the biologit Database retrieved >81k hits covering 31 countries; 19 ICSRs in 10 countries were identified. One specific example includes a non-English Peruvian article Peru that was not indexed in PubMed but was auto-translated by the biologit Platform. This article included a case of a 43-year-old woman who developed metamizole-induced agranulocytosis.
Keep an eye on the biologit page for publication of this case study and discover how you can achieve up to 50% time-saving efficiency with your team!
FDA approves Kisunla: A new hope for Alzheimer's treatment amid safety precautions
On the 2nd of July 2024, the FDA approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.
This should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease. It is administered as an intravenous infusion every four weeks. The prescribing information includes a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain. ARIA usually does not have symptoms, although serious and life-threatening events rarely can occur. This approval emphasises the importance of innovative treatments in improving patient outcomes and managing Alzheimer's disease, offering hope for enhanced quality of life for patients and their families.
For more details, visit: FDA approves treatment for adults with Alzheimer’s disease | FDA
FDA and EMA enhance Parallel Scientific Advice Program to boost animal drug development
The U.S. FDA’s Centre for Veterinary Medicine (CVM) and the European Medicines Agency (EMA) recently announced updates to the Parallel Scientific Advice (PSA) program for new animal drug products to increase harmonisation and facilitate development of new products to support animal health.
While the program has existed for more than 15 years, recent updates include an addition of a trilateral meeting with the sponsor and both agencies; defined timelines for scientific advice and feedback; and preliminary written feedback to the sponsor. The FDA encourages animal drug sponsors who are interested in developing drug products for both the U.S. and European markets to engage the agencies and take advantage of this program, which aims to streamline development of new animal drugs.
Further information can be located here: FDA and European Medicines Agency Announce Updates to Parallel Scientific Advice Program for New Animal Drugs | FDA
EMA mandates QPPV email address update in Union Product Database for limited time
On the 13th of June 2024, EMA released that between August and September 2024, marketing authorisation holders will be required to manually add to Union Product Database (UPD) the relevant email addresses of the Qualified Person for Pharmacovigilance (QPPV) for their products, without submitting a Variation Not Requiring Assessment (VNRA). Currently, UPD only contains the name and location of the QPPV. This feature will be available for a limited time and is only for adding the QPPV email address. Detailed information will be communicated in advance via email to all industry users registered in the UPD in the upcoming weeks.
More information on this can be found at UPD 1.7.2424 Release Notes (europa.eu)
New EU guidance streamlines clinical evaluation of orphan medical devices under MDR
The European Commission has released new guidance on the clinical evaluation of orphan medical devices, marking a significant step in addressing the needs of patients with rare conditions.
Orphan devices are designed for diseases or conditions affecting a very small number of individuals annually and often serve as critical solutions in the absence of other diagnostic or therapeutic options. The guidance outlines criteria for identifying a device or accessory as an 'orphan device' under the Medical Devices Regulation 2017/745 (MDR). It provides essential instructions for manufacturers and notified bodies on how to apply the MDR’s clinical evidence requirements and aims to mitigate delays in patient access to these crucial devices. Additionally, it allows for consultation with European Medicines Agency expert panels to discuss orphan device status and the necessary clinical data. Developed by the Medical Devices Coordination Group (MDCG) in collaboration with various stakeholders, this guidance is a key initiative to support manufacturers and enhance notified body capacity, facilitating a smoother transition to the Medical Devices Regulations.
For more details, go to MDCG 2024-10 Clinical evaluation of orphan medical devices (europa.eu)
EMA will host public launch of updated pharmacovigilance guidelines on risk minimisation measures
The EMA is organising a public launch event for the updated guideline on Good Pharmacovigilance Practices (GVP) Module XVI and its Addendum II, with a focus on risk minimisation measures. Scheduled for September 11, 2024, this online event will cover the integration of public feedback into the guidelines. It will also include a Q&A session. Presentations will be given by representatives from the Pharmacovigilance Risk Assessment Committee (PRAC) and EMA. The objective of this initiative is to improve the safety and efficacy of medicinal products by optimising risk management strategies.
For more information and to register: EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II | European Medicines Agency (europa.eu)
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biologit MLM-AI is a complete literature screening platform built for pharmacovigilance, medical device and veterinary vigilance teams. Its flexible workflow, unified global scientific database, which includes local journals and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs. Teams can save up to 70% of their time and work collaboratively across departments.
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