The Cures Act creates an opportunity for the FDA to apply recent advances in technology and analytics
and scienti c and evidentiary models to continue evolving regulatory programs. Moreover, the new administration’s focus on reducing regulatory
burden could spur agencies to move towards a more collaborative, adaptive approach to regulating therapies, and create regulatory exibility that also supports patient access and public safety.
In many ways, the drug, device, and diagnostic development and approval process of yesterday is over. Life sciences companies (biopharma, medical device, and diagnostics companies) may risk being out of date and competitively disadvantaged if they are not pursuing the newer breakthrough, priority, or accelerated pathways included in the Cures Act and in some of the initiatives the FDA has developed in the past several years. As the industry strives to meet the evolving needs of stakeholders—patients, providers, and health plans— this regulatory exibility will likely be imperative to drive both regulatory approval and market access.