FDA Releases New and Revised Product-Specific Generic Drug Guidance

On May 16, 2017, FDA announced that it had released several new and revised guidance documents describing the agency’s expectations on the development of generic-drug products. Some of the documents also provide discussion on data formats. The agency hopes the documents will assist generic-drug makers to identify methodology for developing drugs and generating evidence for abbreviated new drug applications (ANDAs).

FDA states that ANDA applicants should show that their generic-drug products are pharmaceutically and therapeutically equivalent, as well as bioequivalent, to their reference listed drug (RLD). Applicants must conduct bioequivalence testing “using the most accurate, sensitive, and reproducible approach available among those set forth in 21 Code of Federal Regulations 320.24.” The guidance documents are provided to help companies “to develop generic drug products therapeutically equivalent to specific reference-listed drugs.”  

Public comment on the guidance documents can be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015; www.regulations.gov; or to to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.