FDA CRL Insights

Understand where drug applications fail and how seemingly small gaps in CCIT strategy or validation can trigger major regulatory consequences.

 

What regulators expect

Learn what FDA reviewers expect for probabilistic vs. deterministic methods, including detection capability, reproducibility, and lifecycle coverage.

 

Practical strategies

Discover how to select fit-for-purpose methods, define leakage limits, generate defensible validation data, and avoid costly approval delays.