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Extractables and Leachables (E&L) issues are quietly derailing nearly one in five drug applications.
Released By Solvias
January 29, 2026
Extractables and Leachables (E&L) issues are quietly derailing nearly one in five drug applications, as shown by hundreds of recent FDA Complete Response Letters. This white paper reveals the most common mistakes behind these setbacks—and offers practical, expert-backed strategies to build stronger E&L programs that protect timelines and speed products to market.
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