FDA Announces Draft Guidance on RWD in Pharmacoepidemiological Studies
The FDA published a landmark guidance outlining "M14 General Principles for Preparing, Planning, Design, and Analysis of Pharmacoepidemiological Studies That Use Real-World Data Sources." To this end, it sets out to underscore the importance of RWE in drug development, post-market surveillance, and regulatory decision-making.
Key Technical Aspects of the Guidance
Implications for Pharmacoepidemiological Research
This guidance document is one of the critical steps toward the standardization of RWE applications in regulatory settings:, it details a framework for the design, conduct, and reporting of high-quality pharmacoepidemiological studies using real-world data sources.
Key implications include:
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Maxis Clinical Sciences' RWE Services
Our RWE services at Maxis Clinical Sciences are very much aligned with the FDA's guidance on pharmacoepidemiological studies using real-world data. We have bundled an integrated package of services to help sponsors through all phases of RWE study execution while adhering to regulatory requirements and best practices.
Through a partnership with Maxis Clinical Sciences, sponsors can ensure that their RWE initiatives not only meet but exceed the standards set forth in the FDA guidance. Our team of experienced epidemiologists, biostatisticians, data scientists, and regulatory experts work collaboratively to deliver high-quality, regulatory-grade real-world evidence.
Whether you're planning a post-marketing safety study, exploring a new indication for an existing product, or seeking to complement your clinical trial data with real-world insights, our tailored RWE services can support your objectives while ensuring alignment with the latest regulatory expectations.
Please follow this link to our website or consult our experts to find out more about how we can support your specific RWE needs and expertly guide you on how to effectively manage the changing real-world evidence landscape within drug development and post-marketing surveillance.
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