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.
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