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mHealth Set to Transform Clinical Trials
The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June-an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.
The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June-an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.
The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices. It also signaled that IT products that straddle the line between IT and devices would also be exempt. This is good news for mHealth solution developers and health sciences organizations engaged in clinical development, clearing the way for faster development and more confident adoption.
In this Applied Clinical Trials article, Oracle Health Science’s Mukhtar Ahmed outlines mHealth technologies’ potential to transform clinical development programs, including clinical trials.
Beyond the Birthrate: The Societal Costs of Maternal Mortality
September 6th 2024Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
Efsitora Demonstrates Non-Inferiority vs. Insulin Glargine, Degludec for Type 2 Diabetes
September 5th 2024Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora compared to daily insulin glargine and degludec.
