As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with the FDA.

In 2002, the FDA created a set of procedures for these consults. The procedures are for FDA staff to follow when requesting, receiving, handling, processing, and tracking formal reviews of combination products.

This creates complex regulatory challenges for both the FDA and the developer of the product. The regulatory challenge with combination products is that there are many different combinations of products, which means that no one set of manufacturing rules will apply to them all. The FDA’s draft guidance is an attempt to clarify how to apply the agency’s rules to different situations.

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