What FDA CRLs Reveal About E&L

The FDA’s recent release of 202 Complete Response Letters offers an unusually transparent look into the regulatory missteps that continue to hold drug developers back. Nearly one in five of these letters cited deficiencies in extractables and leachables (E&L) programs—an unmistakable signal that gaps in analytical strategy, compound identification, and toxicological justification remain widespread across the industry. This white paper unpacks those recurring issues, revealing why unknown compounds above safety thresholds and insufficient toxicological risk assessments appear so frequently in regulatory feedback.

Readers will gain clarity on systemic pitfalls, including delayed E&L planning, misinterpretation of regulatory thresholds, and overreliance on generic testing templates. The analysis also highlights the growing importance of advanced analytical tools, read‑across toxicology approaches, and early integration of E&L considerations into product and packaging design.

For organizations aiming to prevent costly delays, this resource delivers actionable guidance rooted in real FDA data. It outlines practical steps to build risk‑based E&L strategies that withstand regulatory scrutiny and protect development timelines. Download the full white paper to explore the findings in detail and benchmark your current E&L approach against emerging expectations.