371 Page Proposed Rule for Implementation of MMA ANDA and 505(b)(2) Provisions

Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.