CRL Risk Analysis: A Deeper Dive into FDA’s Newly Published Letters

Presented on Tuesday, July 22, 2025

The FDA recently published ~200 Complete Response Letters (CRLs) as part of a new transparency initiative. Over 90% were previously published in drug approval packages, and Redica Systems (in partnership with PDA) already performed a comprehensive analysis of GMP-related CRLs from 2022 to 2024.

Please download our updated CRL analysis, where we will review the following:

• Redica Methodology to identify the FDA inspection for the CRL from the drug approval package
• Top 483 observation issues related to the CRLs through observation cluster analysis
• CRL inspection risk model based on the observation cluster analysis and relevant inspection metadata