Events | 2022.01.18
Next-Generation Rett Syndrome Global Registry Designed to Unify Disparate Patient Data to Support Clinical Development Receives Positive Feedback from FDA
The innovative Rett Syndrome Global Registry presented to the Food and Drug Administration (FDA) was met with enthusiasm by agency leadership and begins a collaborative relationship aimed to maximize the registry’s use in the development of novel therapeutics. The non-regulatory meeting allowed the agency to provide high-level feedback on the registry’s clinical trial-grade design. The Global Registry will take a new approach to understanding Rett syndrome by unifying patient data captured from a variety of sources into a single, clinical trial-grade registry. Data sources will include information reported by caregivers, data extracted from patient medical records, input from patient cell lines, clinical trials, and, eventually, wearable and non-wearable biosensor readouts. The comprehensive data sets that emerge will provide caregivers, researchers, biopharmaceutical companies, and regulators with the most unified picture of Rett syndrome to date.
(PRWeb January 18, 2022)
Read the full story at https://www.prweb.com/releases/2022/1/prweb18439590.htm
For more information, please visit
https://www.prweb.com/releases/2022/1/prweb18439590.htm
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