Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonclinical Safety Evaluation of Drug Combinations, which offers recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products, copackaged products, and adjunctive therapies. A fixed-dose combination product is one in which two or more separate drug components (active pharmaceutical ingredients) are combined in a single dosage form. A copackaged product consists of two or more separate drug products in their final dosage form, packaged together with appropriate labeling to support the combination use. An adjunctive therapy refers to the situation in which a patient is maintained on a second drug product that is used together with the primary treatment, although the relative doses are not fixed and the drugs need not be given at the same time. To download the draft guidance, click here. To view this notice, click here.
