论文标题
美国医学产品调节性复杂性对创新的影响：相互依存，早期加速和随后反转的初步证据
The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion
论文作者
论文摘要
医疗产品（药物和医疗设备）法规的复杂性会影响美国的创新吗？如果是这样，怎么样？在这里，该问题的研究如下：从1976 - 2020年开始的各种新颖的调节指标（FDA发行的指南）和创新（相应的FDA注册）用于确定相互依存，这一概念，依赖于强相关性和相互因果关系（通过可变的落叶传输转移熵和波动均可估算）。基于这种相互依存，进行了对创新的监管映射，并发现监管似乎加速了，然后才支持创新，直到2015年左右。在那个时候，出现了一个倒的U-Curve。如果从经验上证据，就已经达到了一个重要的创新调节联系。因此，利益相关者应（重新）考虑监管景观的复杂性，以增强美国医疗产品创新。研究局限性，扩展和进一步的想法完成了这项研究。
Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovation (corresponding FDA-registrations) from 1976-2020 are used to determine interdependence, a concept relying on strong correlation and reciprocal causality (estimated via variable lag transfer entropy and wavelet coherence). Based on this interdependence, a mapping of regulation onto innovation is conducted and finds that regulation seems to accelerate then supports innovation until on or around 2015; at which time, an inverted U-curve emerged. If empirically evidentiary, an important innovation-regulation nexus in the US has been reached; and, as such, stakeholders should (re)consider the complexity of the regulatory landscape to enhance US medical product innovation. Study limitations, extensions, and further thoughts complete this investigation.
