Best Practices in the Curation and Use of Real-world Data in the Regulatory Pathway

Rahul Dhanda¹*, Ching-Kun Wang² and Andrew J Belli^2
1Rangam Incorporated and University of Texas Health, USA
²COTA, Inc. USA
*Corresponding Author: Rahul Dhanda, Rangam Incorporated and University of Texas Health, USA.

Published: October 28, 2023

DOI: 10.55162/MCMS.05.173

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Abstract  

The fit-for-use of RWD including data quality and provenance are critical components that will aid the Federal Drug Administration (FDA) to assess the adequacy of RWE (Real World Evidence) to support it on the regulatory pathway. We review the best practice in the curation and use of Real World data in support of RWE submissions to the FDA.

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