How are products that combine two or more drugs regulated?
A product that combines two or more drugs (without including a device or biological product) is not a combination product as defined in 21 CFR 3.2(e). The Center for Drug Evaluation and Research (CDER) regulates combination drug products, including those that involve drugs provided in a single dosage form (“fixed combination” drug products) or as separate co-packaged drug products. 21 CFR 300.50 provides specific requirements for fixed combination prescription drug products. Draft guidance on Nonclinical Safety Evaluation of Drug Combinations is also available at http://www.fda.gov/oc/combination/default.htm. You should refer any specific questions about combination drug products to the responsible reviewing Division in CDER’s Office of New Drugs http://www.fda.gov/cder/cderorg/OND.htm. If you are unsure which CDER Division would be responsible for the review of your product, or if you have a general inquiry, please contact the Regulatory Affairs Team in CDER’s Office of New Drugs at (
A product that combines two or more drugs (without including a device or biological product) is not a combination product as defined in 21 CFR 3.2(e). The Center for Drug Evaluation and Research (CDER) regulates combination drug products, including those that involve drugs provided in a single dosage form (“fixed combination” drug products) or as separate co-packaged drug products. 21 CFR 300.50 provides specific requirements for fixed combination prescription drug products. You should refer any specific questions about combination drug products to the responsible reviewing Division in CDER’s Office of New Drugs. If you are unsure which CDER Division would be responsible for the review of your product, or if you have a general inquiry, please contact the Regulatory Affairs Team in CDER’s Office of New Drugs at (301) 796-0700.
