FDA Issues Guidelines for Interface Design, Human Factors in proposed Generic Combination Products

The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device combination product and the user interface of its Reference Listed Drug (RLD). Significant differences can cause serious user-related errors and so the FDA expects that patients and lay-persons can safely use an approved generic combination product appropriately when it is substituted for the RLD. See: http://www.meddeviceonline.com/doc/fda-describes-how-interface-design-and-human-factors-support-approval-of-generic-combination-products-0001