FDA Issues Guidance on Nonclinical Evaluations of Drug Combinations

The FDA has released a draft guidance providing recommendations on nonclinical safety evaluations to support the clinical study and approval of drug combinations, including fixed-dose combination products, co-packaged products and adjunctive therapies.

The draft guidance includes recommendations for three subgroups of drug combinations: combinations involving only previously marketed drugs; combinations including one or more new molecular entities (NMEs) and one or more previously marketed drugs; and combinations consisting of more than one NME.

The FDA said it elected to discuss the drug combination types separately because nonclinical studies may differ for each type based on the toxicologic and pharmacokinetic profiles of the individual drugs, the treatment indication or indications, or the target population.

To view the draft guidance, titled "Nonclinical Safety Evaluation of Drug Combinations," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0004-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0004-gdl0001.pdf).