FDA Issues Draft Guidance On Reference Product Exclusivity For Biologics

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On August 4, 2014, FDA issued a draft guidance titled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.

United States Food, Drugs, Healthcare, Life Sciences

On August 4, 2014, FDA issued a draft guidance titled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act. The draft guidance is intended to help biological product sponsors and applicants in submitting appropriate information to FDA to enable the Agency to make a regulatory determination of the "first licensure" date of a reference biological product. Click here for a Jones Day Commentary on the new draft guidance.

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