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21st Century Cures

Optimizing Real-World Evidence in Medical Device Development

C T2023-11-15T17:41:20-05:00January 30th, 2020|Categories: Blog|Tags: 21st Century Cures, 522-mandate, HealthCore-NERI, medical devices, real world evidence, RWD, tHEORetically Speaking|

The use of real-world data to generate RWE for medical devices by industry has become more prominent in recent years, and more attractive to a variety of stakeholders. It is used frequently to understand the use of the device in the larger clinical setting, but more recently it is also being used for regulatory decision making.

Building Trust In Real World Evidence – From Regulators To Patients

C T2023-11-14T19:32:56-05:00April 30th, 2018|Categories: Blog|Tags: 21st Century Cures, Big Data, data security, market access, master data management, MDM, real world evidence, RWE, tHEORetically Speaking|

Bill Fox Chief Strategist for Global Healthcare, Life Sciences, and Insurance MarkLogic In a climate of growing consumer [...]

21st Century Cures and Off-Label Promotion Benefit HEOR and Drug Safety

C T2023-11-15T17:41:29-05:00June 4th, 2015|Categories: Blog, HEOR Feature|Tags: 21st Century Cures, Adverse Events, FDA, FDAMA 114, Health Economic Models, Health informatics, tHEORetically Speaking, transparency|

By Jim Davis As my writing for the AdverseEvents Blog can attest, I’m in favor of data transparency. [...]