Food and Drug Administration (FDA)

These days, enforcing FDA compliance and mentoring new team members are more challenging than ever, thanks to a workforce that is more remote, international, and diverse. [...] With these changes, pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive... Read More »

Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative. Bio-IT World dug into the genesis of precisionFDA and its implications in a feature this week.

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Humetrix, a provider of m-health and analytics platforms, will showcase three of its award-winning mobile platforms: iBlueButton, SOS QR and TENSIO, at today’s Digital Health Technology Expo at FDA headquarters. iBlueButton allows millions of healthcare consumers and their caregivers to receive, annotate, store and share their records, while keeping the data secure and under the patient’s direct control on their own device. Because of Humetrix’s unique approach, the company’s platforms have been chosen by U.S. and European public and private healthcare organizations for care coordination, chronic care management and personal safety...

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Drug companies tend to be secretive, to say the least, about studies of their medicines. For years, negative trials would not even be published. Except for the U.S. Food and Drug Administration, nobody got to look at the raw information behind those studies. The medical data behind important drugs, devices, and other products was kept shrouded. Read More »

The government-mandated push to implement electronic health records is supposed to centralize patient data, and reduce human medical errors in the process. [...] Read More »

Connected health infrastructure is emerging as a binding agent for diverse devices and workflows, aiding diagnosis, monitoring and prevention in the healthcare industry. For such an infrastructure to be efficient, stakeholders must first ensure that interoperability and connectivity standards are in place. New analysis from Frost & Sullivan, Healthcare and Medical Device Connectivity and Interoperability, finds that the adoption of connected healthcare infrastructure is not uniform across the world. This is primarily due to the lack of a holistic digital healthcare strategy that focuses on integrated care models.

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In the summer of 2006, consumers across the country began falling sick from a particularly nasty strain of Escherichia coli bacteria, known as 0157:H7. Not all E. coli bacteria are dangerous, but 0157:H7 belongs to the Shiga toxin-producing group of pathogens (known as STEC), which can cause severe, and sometimes fatal, illness. By early October, 199 people in twenty-six states had fallen ill, resulting in 102 hospitalizations and thirty-one cases of kidney failure. Three people died, including a two-year-old boy in Utah...

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