By: Theresa M. Mullin, Ph.D. Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. I am pleased to have been in China recently, when the China Food and Drug […]
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FDA unveils digital health technology changes
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Get the full story here at the Emergo Group’s blog. The […]
Chinese regulators answer two common clinical trial questions
By Stewart Eisenhart, Emergo Group China Food and Drug Administration (CFDA) regulators have addressed frequently asked questions regarding clinical trial requirements for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com or its […]
Using robot assistance in neurosurgery for faster seizure mapping
Head shaved, a little boy rests on the operating table, deep under anesthesia. His parents have brought him to Boston Children’s Hospital in hopes of determining the cause of his seizures. Now, neurosurgeons Scellig Stone, MD, PhD, Joseph Madsen, MD, and their colleagues in the Epilepsy Center are performing a procedure designed to monitor seizure […]
India publishes essential principles for medical device and IVD safety and performance
By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, is seeking input from industry on draft essential safety and performance principles included in new regulations launching in 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
FDA announces new steps to empower consumers and advance digital healthcare
By: Scott Gottlieb, M.D. When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery. It includes empowering consumers to take more control of their own healthcare information to make better informed […]
Patient Reps: Bringing the voice of patients to FDA
By: Jack Kalavritinos At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients. Increasingly, that means taking into account the views and expertise of patients and their caregivers, because they provide a unique voice and perspective and know best […]
FDA sets inaugural meeting of first-ever Patient Engagement Advisory Committee
By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage. Maybe you participated in a clinical […]
Chinese regulators identify first round of medical device clinical trial inspections
By Stewart Eisenhart, Emergo Group Following its recent announcement of a new inspection program for medical device clinical trial sites, the China Food and Drug Administration (CFDA) has identified the first round of sites that will undergo such inspections. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog […]
FDA unveils new policy for accepting medical device consensus standards
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have disclosed a new process for evaluating and accepting voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
