New Guidance Expected on Combination Products

The FDA’s Office of Combination Products (OCP) is planning to release a number of new guidances on imaging agents, auto-injectors and other products. These documents include a draft guidance on different regulatory pathways for manufacturers of imaging devices used with contrast agents or radiopharmaceuticals; the draft will be issued by Sept. 30 and made final within a year, Thinh Nguyen, OCP director, said last week. Other guidances being prepared include one on cross-labeling, one for chemical/metabolic/physical action, one that revises good manufacturing practices and two on auto-injectors.