Draft Guidance on Effect of Medicare Law on Listed Drugs
11/04/2004
Federal Register Notice: FDA is making available a draft guidance for industry entitled Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare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 document follows the 12/8/03 enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). 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 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 In addition to the definition of “listed drug,” the draft guidance clarifies certain other provisions of the MMA that significantly change the law that existed before the MMA's enactment.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 on 30-month stays and approval of ANDAs and new drug applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (505(b)(2) applications). The draft guidance also explains the effective dates that apply to the MMA's provisions. To download this guidance, click here. To view this notice, click here.
