Understanding the 505(b)(2) Approval Pathway

A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method gains approval for new drugs in a fraction of the time and cost required by traditional paths. This application note describes the features and benefits of the 505(b)(2) approval pathway.