Newsletter - June 2, 2016
Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA
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, biologics and other regulated products for human and veterinary use. Read More..
Is the Use of Wearable Devices in Clinical Trials Over-Hyped?
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, industry analysts projected that use of wearable devices could increase 4 folds in the next 4 years (from about $5 billion to almost $19 billion by the year 2020). Read More..
Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA
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, biologics and other regulated products for human and veterinary use. Read More..
Is the Use of Wearable Devices in Clinical Trials Over-Hyped?
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, industry analysts projected that use of wearable devices could increase 4 folds in the next 4 years (from about $5 billion to almost $19 billion by the year 2020). Read More..
