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.

cell and gene therapy

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.

mobile phone connected to smart watch

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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