Take two and Tweet me in the Morning: How Social Media is Reshaping Health Care
July 11th 2018Given the rapid changes in the communication landscape brought about by participative Internet use and social media, it is important to develop a better understanding of these technologies and their impact on health communication.
Is Europe Creating a Coalition to Combat Big Pharma?
June 26th 2018The late-June announcement that Ireland is joining the Beneluxa Initiative on Pharmaceutical Policy might suggest renewed vigour for the drive to equip national governments with more clout in their pricing negotiations with international drug firms.
Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?
June 25th 2018The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
Medical Monitoring Risk Exposure in New Regulatory Climate
June 6th 2018In this article, we will discuss trends and challenges with medical monitoring clinical analytics, analyze the alignment of existing medical monitoring tools and technologies with ICH-E6 (R2) addendum guidelines, and discuss trends in medical monitoring insourcing and outsourcing models.
FDA Moves to Overhaul New Drug Review Process
May 7th 2018FDA officials make efforts to better manage the increasing amount of applications for new drugs that treat disease in innovative ways and include new kinds of clinical research, starting with a plan to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER).