A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last many years, leading many to complain that the current system poses a substantial barrier to innovation. While the Cures Act represents only a partial patch to the existing system, several provisions of the new law seek to bring consistency and efficiency to this complex area of regulation.

One of the most controversial areas of combination product regulation over the past several years has been the determination of a product's "primary mode of action", which in turn determines the FDA center that will have primary oversight for a specific product, as well as the path to market that the product must take.

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