Draft Guidance for Industry on Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription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; Availability; Correction

摘要

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of November 4, 2004. This document announced the availability of a draft guidance for industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare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." The document was published with an incorrect docket number. This document corrects that error.