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The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices.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.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.