Regulatory Science Series

Shaping Innovative Regulatory Decision Making

The Regulatory Science Series expands the visibility of applied learnings that advance innovations, improve public health and explain complex topics. They feature a range of regulatory science topics, including real world data (RWD), real world evidence (RWE), clinical trial design, digital health technologies, drug safety, and post-market surveillance.

Practical Insights for Cell and Gene Therapy Long-term Follow-up Studies

Helping regulators develop new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of regulated medical products.

Expanding Access to Home-Use Medical Technologies

Expanding access to home-use technologies can help bridge the healthcare gap and advance health equity. However, there are challenges and opportunities associated with developing, evaluating, and monitoring home-use technologies, such as ensuring usability, reliability, connectivity, security, privacy, and patient safety.

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