The West Blog
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September 18, 2018
FDA on the Issue of Packaging Components: Extractables/Leachables Control
<span>Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an <a href="https://www.youtube.com/watch?v=mol_X2zQeig">interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs</a>, discussing FDA’s approach to evaluating E&L information </span>
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