FDA s Longtime Approach To New Chemical Entity Designations Now Codified
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FDA s Longtime Approach To New Chemical Entity Designations Now Codified
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On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by the U.S. Food and Drug Administration for awarding exclusivity to drug products that introduce a new chemical entity as its active ingredient. Although the legislation endorses the regulatory status quo, it is nonetheless important because a judicial decision had questioned whether, in the case of drug products that are mixtures, FDA’s approach conflicted with the text of the statute and improperly narrowed when exclusivity is available. By codifying FDA’s approach, Congress has now resolved that objection, shutting down a potential argument for exclusivity by sponsors of new drug applications.