…world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” I say, let’s also include a 21st-century addendum, “Do not deceive.”…
…world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” I say, let’s also include a 21st-century addendum, “Do not deceive.”…
…as a core aspect of an organization’s mission has emerged as the signature driver of business sustainability in the 21st century. Data integrity is foundational to meeting these expectations. But…
…as a core aspect of an organization’s mission has emerged as the signature driver of business sustainability in the 21st century. Data integrity is foundational to meeting these expectations. But…
Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase…
Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase…
…As we are transitioning to value-based care, the 21st Century Cures Act from 2016 makes it mandatory to share data, unless some specific exceptions can be invoked. This shift from…
…As we are transitioning to value-based care, the 21st Century Cures Act from 2016 makes it mandatory to share data, unless some specific exceptions can be invoked. This shift from…
…be raging in distant Ukraine, danger is anything but remote. In the 21st century, warfare has moved beyond guns, bombs, and propaganda. Hence, arsenals of war now include malware, spyware,…
…be raging in distant Ukraine, danger is anything but remote. In the 21st century, warfare has moved beyond guns, bombs, and propaganda. Hence, arsenals of war now include malware, spyware,…
…by the 21st Century Cures Act. These devices are subject to the general limitations to the exemptions in 21 CFR 884.9, 888.9 and 890.9. In four of the five cases,…
…by the 21st Century Cures Act. These devices are subject to the general limitations to the exemptions in 21 CFR 884.9, 888.9 and 890.9. In four of the five cases,…
…Current Good Manufacturing Practice (CGMP) Final Rule, Quality System Regulation, it had an unintended consequence: Industry began validating computer systems to death! At the 21st Year, CSV Has Come of…
…Current Good Manufacturing Practice (CGMP) Final Rule, Quality System Regulation, it had an unintended consequence: Industry began validating computer systems to death! At the 21st Year, CSV Has Come of…
…for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that when assessing a product that has multiple functions,…
…for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that when assessing a product that has multiple functions,…
…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…
…and benefits.” – Scott Gottlieb, M.D., FDA commissioner In a blog on FDA Voice, Gottlieb emphasizes the cost component of developing technology and patient ability to access them. The 21st…
…entrap debris. “FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types…
…entrap debris. “FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types…
