Using Real-World Evidence in Drug and Device Submissions
The FDA is more open than ever before to accepting real-world evidence and data (RWE/RWD) to support medical product applications. But despite several recent guidances, the agency’s criteria for acceptable data remain murky.
To learn what the agency considers RWE and how to make full use of it in your FDA applications, turn to Using Real-World Evidence in Drug and Device Submissions, a guide to make gathering appropriate RWE/RWD easier and enable you to submit exactly what the FDA is looking for.
Freshly updated to consider new FDA guidance and pilot programs as well as recent examples of RWE use in regulatory decision-making, Using Real-World Evidence in Drug and Device Submissions offers case studies and actionable insights into the data the FDA is likely to accept in support of a medical product application. The guide touches on the Advancing RWE Program, guidance documents related to RWE for drugs and biologics, and the FDA’s 2021 analysis of 90 RWE/RWD usages for medical device application. It also walks you through what these examples reveal about acceptable data and how the agency’s drug-focused guidance may be applied to devices as well.
- Learn the acceptable sources of RWD.
- Understand the primary factors the FDA considers for evaluating the reliability of RWD.
- Discover how the FDA is favoring “clinical trial-like” RWD, such as data from registries.
- Recognize the importance of data quality control.
- Dissect the challenges of using less-than-perfect data to leverage RWE in medical product submissions.
Acquire insights into the ideal RWE/RWD data to use in your product applications today with Using Real-World Evidence in Drug and Device Submissions.
About the Contributors
Kristin Zielinski Duggan is a partner in the Washington, D.C., law firm, Hogan Lovells and advises companies on the development and regulation of medical devices, pharmaceuticals and combination products. She is also an adjunct professor at Georgetown University's School of Nursing and Health Studies, where she teaches a seminar on FDA regulation of medical products.
Sally Gu is a senior associate at Hogan Lovells, where she advises clients on advertising and promotion issues, compliance with current good manufacturing practice (cGMP), lifecycle management and product development issues.
Who Will Benefit
- Drug and biologics developers and manufacturers
- Medical device developers, engineers and manufacturers
- Quality and regulatory professionals
- Researchers and clinical trial professionals
- Software engineers
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Kristin Zielinski Duggan and Sally Gu
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