Sponsors Continue to Look to Aleon for Combination Product INDs

December 2022

Combination Drug Product IND for FDA

Aleon Pharma International, Inc. is supporting several Investigational New Drug Applications (INDs) for combination products, including an upcoming submission this year. A combination product is defined in 21 CFR 3.2(e), but is generally described as a product that involves some combination of a drug, biologic or device. These submissions can be more difficult than a traditional IND, and present regulatory challenges that are tricky to predict when a sponsor begins preparing an IND. Combination products involve different medical product centers within the FDA. While traditional products have a corresponding center within the FDA (such as The Center for Biologics Evaluation and Research – CBER, the Center for Drug Evaluation and Research – CDER, or the Center for Devices and Radiological Health – CDRH), combination products often involve multiple centers as well as the Office of Combination Products. This can make approval challenging as the submissions involve components that could be evaluated under different authorities raising questions about policy and review. The FDA has put together a Combination Products Policy Council (https://www.fda.gov/combination-products/about-combination-products/combination-products-policy-council) to resolve questions and guide policy, but when a sponsor’s approval is on the line, support from a firm like Aleon can help to avoid issues before they arise and avoid any potential delay. The FDA predicts an increasing number of combination product INDs as product types further overlap and combination research continues, so experience and connections within the FDA will continue to be indispensable assets when planning for a combination product submission. Aleon has successfully supported several of these INDs without issue and is currently preparing multiple INDs for combination therapies. We are well positioned to support sponsors looking at combination product approvals by the FDA.