Home > Insights > Blogs > Life Sciences Decoded

Life Sciences Decoded

Life Sciences Decoded

(By accessing, browsing or using the pages below, you agree to the Blog Conditions of Use/Disclaimer available under "Links.")

Posts

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

Diane Romza-Kutz Matt Hafter April 12, 2017
health-future-medical-app_23855425774_o

The proliferation of Internet-connected and controlled medical devices opens up bundle of cybersecurity risks and concerns. What stance has the FDA taken so far an where is it headed? READ MORE

FDA-regulated industries: Plan now for these changes in 2016

Diane Romza-Kutz Fredric Roth V January 28, 2016
planningstrategy_24303008709_o

Big changes are in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. READ MORE

FDA Update: New guidance released on mobile medical devices, medical devices data systems

medicaltablet_20682794496_o

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the medical industry as a potential source of revenue. READ MORE

FDA launches medical device database: AccessGUDID

accessgudid_19138817358_o

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July of 2012. READ MORE