On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development and delivery” of innovative products, including by adding and modifying various programs administered by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the new legislation broadly affects research and development, it is also significant for issues it does not address:
1. The law codifies several mechanisms intended to facilitate product development but does not change the evidentiary standards for clearance and approval.
2. The law includes provisions about clinical decision support software but leaves key digital health questions unanswered and raises new ones.
3. The law made some clarifying changes related to communication of healthcare economic information (HCEI), but questions remain.
4. Some of the law’s more obscure provisions regarding clinical trials and combination products are likely to provide the most practical near-term benefit to drug and device firms.
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Source: Sidley Austin LLP