The Evolution Of 21st Century Cures Legislation
Final version of Cures legislation combines several aspects of initial House and Senate legislation, and also includes some completely new elements.
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Expert panel notes overlap between cultural and structural changes, advises changes in both areas should be implemented together. Recommendations for culture changes include “commit to an on-going process of culture change from the highest levels of FDA leadership.”
Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?
FDA says its "traditional approach" for hardware-based medical devices of moderate and higher risks "is not well suited for the faster iterative design, development and type of validation used for software-based medical technologies. Digital technologies such as mobile apps likely will have a role in facilitating additional Rx-to-OTC drug switches.