This past May, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).
FDA believes that review of both positive and negative data may be “important in our determination of whether a product is bioequivalent to the RLD and are relevant to our evaluation of generic products in general,” according to the guidance. “These data will increase our understanding of generic drug development and how changes in components and composition may affect formulation performance, as well as promote further development of science-based bioequivalence policies,” says the guidance.