Best Practices in the Curation and Use of Real-world Data in the Regulatory Pathway
Rahul Dhanda1*, Ching-Kun Wang2 and Andrew J Belli2
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
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.