Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act." Among other things, this guidance provides FDA's current thinking on what constitutes a 505(q) petition and describes some of the considerations that FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application. This guidance finalizes the draft guidance for industry entitled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act" issued in October 2018.