Day: June 1, 2016

Wearable devices such as smart watches, fitness devices, smart phones and mobile phone apps, and other such gadgets can be used to collect useful health-related information about the individual using them. It is often thought that using such devices one can track important clinical trial information and increase accuracy, speed and reliability of data. Recently, … Read more

FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more