To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes.
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Summary
Based on the bill's title, this measure would amend the Federal Food, Drug, and Cosmetic Act to clarify procedures for rejecting petitions that are primarily intended to delay approval of drug applications under specified pathways. The bill targets petitions filed under subsection (q) of section 505, which governs the review process for new drug applications. The specific mechanics of the clarification are not available from the title alone.
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