Industry Insights

  1. Nearly 20% Of FDA CRLs Published In 2025 Cite E&L Deficiencies. How Can You Avoid Them? 2/20/2026

    If your Extractables & Leachables (E&L) strategy isn’t built early — and built right — it can quickly turn into a regulatory roadblock.

  2. What FDA CRLs Reveal About E&L 2/18/2026

    FDA feedback shows E&L gaps still delay approvals. This preview flags common issues — from unknown compounds to weak tox data — and offers ways to strengthen E&L approaches and cut regulatory risk.