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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&amp;L) is an essential element of determining the suitability of a packaging or delivery system for a drug product.&nbsp; 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&rsquo;s Office of New Drugs</a>, discussing FDA&rsquo;s approach to evaluating E&amp;L information </span>
West Pharma

Lindsay Reinhold

Supervisor, Laboratory

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