Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of Abbreviated New Drug Applications and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003-Questions and Answers; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003--Questions and Answers." This draft guidance follows the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) (MMA) on December 8, 2003. In part, this guidance satisfies FDA's obligation under that law to clarify the definition of "listed drug" for persons who wish to submit a change (i.e., an amendment or supplement) to an abbreviated new drug application (ANDA). The guidance explains when a change to an application should reference a drug different from the drug listed in the original ANDA, requiring the change to be made through an entirely new application. In addition to the definition of "listed drug," the draft guidance clarifies certain other provisions of the MMA that significantly change the law that existed before the MMA's enactment. These include changes regarding 30-month stays and approval of ANDAs and new drug applic