The U.S. Food and Drug Administration (FDA) recently published its guidelines related to citizen petitions and petitions for stays of action under section 505(q) of the federal Food, Drug, and Cosmetic Act (a "Petition"). These guidelines detail how the FDA determines if the provisions of section 505(q) apply to a Petition and whether the certification and the verification required for filing with any Petition or supplemental information or comments meet statutory requirements. The FDA also commented on the relationship between review of such Petitions and review of abbreviated new drug application (ANDA) and section 505(b)(2) applications for which the agency has not made a final approvability determination.
Does Section 505(q) Apply to the Petition?
The FDA has determined that section 505(q) applies to Petitions only when the Petition was submitted to the FDA on or after September 27, 2007; the Petition is submitted in writing; an ANDA or section 505(b)(2) application is pending at the time the Petition is submitted; the petitioner requests an action that could delay approval of such application; and the Petition does not fall within an exception to section 505(q).
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