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BIO Comments on FDA's Reference Product Exclusivity Draft Guidance

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The Biotechnology Industry Organization (&ldquo;BIO&rdquo;) thanks the Food and Drug Administration (&ldquo;FDA&rdquo;) for the opportunity to submit comments on the above-referenced Draft Guidance for Industry: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (August 2014) (&ldquo;Exclusivity Draft Guidance&rdquo; or &ldquo;Draft Guidance&rdquo;).</div>