FDA Issues Proposed Rule Regarding Citizen Petitions and PSAs Related to Section 505(b)(2) Applications or ANDAs


As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) enacted on September 27, 2007, Congress added Section 505(q) to the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 355(q)). Section 505(q) applied to certain citizen petitions and petitions for stay of action (PSAs) related to applications submitted under Section 505(b)(2) of the FDCA or an application submitted under Section 505(j) of the FDCA for a generic drug product. Congress enacted Section 505(q) because it believed that the citizen petition process and PSAs were being used to delay approval of generic products. The FDA has now promulgated a proposed rule clarifying how it will implement the Section 505(q) requirements. Highlights of this proposed rule include:

•FDA will calculate the data on which a citizen petitioner or PSA is submitted to FDA as the date that the Division of Dockets Management receives either the citizen petition or the PSA. That is the date on which the 180-day requirement for final action by FDA will begin to run; and...

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