Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act." The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) addressing the agency's treatment of certain citizen petitions and petitions for stay of agency action (collectively, petitions), as well as related applications. The draft guidance describes how FDA will determine if the new provisions apply to a particular petition and how FDA will determine if a petition would delay approval of a pending abbreviated new drug application (ANDA) or 505(b)(2) application. The draft guidance also describes how FDA will interpret the requirements that such petitions include a certification and that supplemental information or comments to such petitions include a verification. The draft guidance also addresses the relationship between the review of petitions and pending ANDAs and 505(b)(2) applications for which the agency has not yet made a decision on approvability.