Abstract The FDA, regulatory agencies, industry, and academia have all made significant progress in determining bioequivalence (interchangebility between generic and the innovator product). The FDA in the United States approves and awards generic medication marketing authorization by applying the regulatory procedures set forth in the Code of Federal Regulations (CFR). The purpose of this article is to review scientific criteria for marketing authorization of generic products.
Keywords Marketing authorization, Generic product, Bioequivalence, Therapeutic interchange.