Federal Register Notice: Due to recent statutory changes, such as the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 signed into law 12/8/03, FDA is requesting public comments on whether additional regulatory actions should be taken on the approval of abbreviated new drug applications. FDA seeks comments that identify relevant issues and resolutions to the issues on Title XI of the Act concerning the 30-month stay of effectiveness period, 180-day exclusivity, and bioavailability and bioequivalence. To view this notice, click here.
