The FDA, as part of the Prescription Drug User Fee Act (PDUFA VII), has committed to reporting aggregate and anonymized information on submissions containing real-world evidence (RWE) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This ongoing reporting aims to enhance understanding and confidence in the integration of #RWE in regulatory decision-making processes. This report includes: 📝 Protocols: FDA reviewed 10 RWE protocols in 2023, with 1 focused on effectiveness and 9 on safety. All 10 aimed to satisfy post-marketing requirements or commitments. 💡 Applications: FDA reviewed 4 applications in 2023 containing de novo RWE for effectiveness or safety purposes. ✅ Approvals Based on RWE: The FDA approved two drugs, Actemra (Genentech) and Vimpat (UCB), based at least in part on RWE. Read more here: https://hubs.li/Q02G5mTh0
Sobre nosotros
Aetion is a health care analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs health care’s most critical decisions — what works best, for whom, and when — to guide product development, commercialization, and payment innovation. Aetion is based in New York City and backed by investors including New Enterprise Associates (NEA), Warburg Pincus, Flare Capital Partners, Greenspring Associates, Lakestar, B Capital, Foresite Capital, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, EDBI, Johnson & Johnson Innovation—JJDC, Inc., UCB, Amgen Ventures, and Horizon Health Services, Inc. Learn more at aetion.com and follow us at @aetioninc.
- Sitio web
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http://aetion.com
Enlace externo para Aetion
- Sector
- Desarrollo de software
- Tamaño de la empresa
- De 201 a 500 empleados
- Sede
- New York, NY
- Tipo
- De financiación privada
- Fundación
- 2012
Ubicaciones
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Principal
5 Penn Plaza
7th Floor
New York, NY 10001, US
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50 Congress St
Suite 1025
Boston, Massachusetts 02109, US
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Carrer Córcega, 381-387
Planta 4 (4th Floor)
Barcelona, 08037 , ES
Empleados en Aetion
Actualizaciones
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ICYMI - Aetion has achieved its first FDA device clearance and label change using real-world data (RWD), collaborating with Intuitive, FDA, and NEST. The revised labeling for Intuitive’s da Vinci X and Xi systems is based on RWD, showing similar long-term survival rates for robotic-assisted and non-robotic radical prostatectomy, showcasing the power of RWD in advancing cancer treatment and regulatory science. Learn more here: https://hubs.li/Q02FggSc0 #Innovation #Healthcare #RoboticSurgery #CancerTreatment #FDA #RWD
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Empowering Healthcare: Global Efforts for Transparent AI in Medical Devices The FDA, Health Canada | Santé Canada, and the U.K. Medicines and Healthcare products Regulatory Agency are collaborating to ensure transparency in #AI-powered medical devices. Building on their 2021 set of best practices, the latest guidelines emphasize transparency for all stakeholders, including health professionals, patients, administrators, payors, and governing bodies. It is our stance that the adoption of AI technologies in health care could lead to great improvements in efficiency, patient care and medical research, accelerating the discoveries that lead to new cures. And as this update outlines specifically for machine learning-enabled medical devices, transparency is a good practice for all applications of AI. Learn more: https://hubs.li/Q02DYWCn0
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Swift insights are crucial for healthcare’s most critical decisions. With Aetion Discover, we bring together our top-tier analytics capabilities with a user-centric interface to serve up insights that are quick, clear, and reliable. Schedule a demo here: https://hubs.li/Q02DYCGp0
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Unlock the potential of sensitive data with Aetion® Generate. Click the link to schedule a demo with us to learn how generative AI is helping users get more from their real-world and clinical data: https://hubs.li/Q02DtvH20
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Now live on the Aetion Evidence Hub, discover how a recent study with Aetion, EMA, and the TREAT-NMD network using #RWD is shaping the future of Spinal Muscular Atrophy research. Find out how registry data is advancing treatment options for rare diseases like SMA. #RareDisease #RealWorldData #SMAResearch. Learn more here: https://hubs.li/Q02DpQqj0
Advancing SMA Treatment: How Real-World Evidence Supports Regulatory Decisions
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Regulators are placing a greater emphasis on understanding how medical products work in historically underrepresented populations. One such approach involves Congress mandating that manufacturers create Diversity Action Plans for products seeking approvals. A new research article from Friends of Cancer Research notes that oncology product manufacturers “now incorporate diversity considerations into their trial planning processes by using epidemiologic data sources to assess disease burden and inform site selection”: https://hubs.li/Q02DgJn10
An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials
aacrjournals.org
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See for yourself why Aetion® Substantiate is the standard-setting #RWE application of choice used by global biopharma organizations, regulators, payers, and health technology assessment bodies—schedule a demo with one of our experts today: https://hubs.li/Q02D4QsN0
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ICYMI—Aetion's Ann Madsen (VP, Science) sat down with The Evidence Base® to discuss the poster—‘An Emulation of the KEYNOTE-189 Trial Using Electronic Health Records’—recently presented at #ISPORAnnual. Here, you'll find out that while the initial pilot didn't match the #RCT results, it laid the groundwork for future emulations and highlighted the potential of #RWE to complement traditional trials. Full article here: https://hubs.li/Q02D4NMT0
Emulating randomized controlled trials in oncology using electronic health record data: an interview with Ann Madsen, Aetion
evidencebaseonline.com
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In a recent blog authored by Nicholaas Honig (Head of Regulatory and Sr. Counsel at Aetion), learn how the need for transparent and rigorous #RWE has never been greater and how Aetion is working to ensure validity in RWE studies with tools like #SPACE and #SPIFD2. Find the full blog now on the Aetion Evidence Hub: https://hubs.li/Q02CJ6yQ0
Quality, Rigor, and Transparency: The RWE Imperative
evidence-hub.aetion.com
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