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Innovation is a critical aspect of medical and pharmaceutical product development, and the U.S. Food and Drug Administration (FDA) encourages and supports such innovative products that can benefit public health. Generally, the FDA considers innovative products to be ones that represent a significant improvement over existing products in terms of safety, efficacy, or patient care.

  • The FDA often categorizes innovative products into two broad categories: "breakthrough" and "novel."

  • A breakthrough product is one that provides a substantial improvement in the treatment, diagnosis, or prevention of a serious or life-threatening disease or condition. To be considered a breakthrough, a product must demonstrate preliminary clinical evidence indicating that it may offer substantial improvement over existing therapies.

  • A novel product, on the other hand, is one that is substantially different from any other product previously approved by the FDA. Novel products may be approved through a variety of regulatory pathways, such as the FDA's Expedited Programs, which are designed to accelerate the development and review of drugs and biologics for serious conditions.

  • Overall, the FDA encourages and supports innovative product development that can improve patient care and advance public health.

innovative products
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