Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human211 Drugs and Biological Products. Clinical 6

摘要

This document is intended to provide guidance to applicants planning to file new211u001edrug applications (NDAs), biologics license applications (BLAs), or applications 211u001efor supplemental indications on the evidence to be provided to demonstrate 211u001eeffectiveness. This document is also intended to meet the requirements of 211u001esubsections 403(b)(1) and (2) of the Food and Drug Administration Modernization 211u001eAct (the Modernization Act) of 1997 for human drug and biological products (P.L. 211u001e105-115). Subsection 403(b)(1) directs FDA to provide 3 guidance on the 211u001ecircumstances in which published matter may be the basis for approval of a 211u001esupplemental application for a new indication. Section III of this guidance 211u001esatisfies this requirement by describing circumstances in which published matter 211u001emay partially or entirely support approval of a supplemental application. 211u001eSubsection 403(b)(2) directs FDA to provide guidance on data requirements that 211u001ewill avoid duplication of previously submitted data by recognizing the 211u001eavailability of data previously submitted in support of an original application 211u001eto support approval of a supplemental application. Section II of this guidance 211u001esatisfies this requirement by describing a range of circumstances in which 211u001erelated existing data, whether from an original application or other sources, may 211u001ebe used to support approval of a supplemental application.