Business · 24/04/2015Updated: 10/17/2026 · 1 min read

FDA Extends Comment Period for Proposed Rule on Abbreviated New Drug Applications and 505(b)(2) Applications

The US Food and Drug Administration (FDA) is extending the comment period for a proposed rule that aims to implement portions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which governs the approval of certain drug applications and amendments to related regulations.