U.S. Food and Drug Administration published the draft guidance for industry titled “Determining Whether to Submit an ANDA or 505(b)(2) Application.” This guidance assists applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) described in sections 505(j) and 505(b)(2) is appropriate for the submission of a marketing application for a human drug product to FDA.