Effective September 26,2012 Health and Human Services has assigned responsibility to FDA for enforcing reporting by sponsors on ClinicalTrials.gov. Based on a notice by the Federal Register, FDA is now responsible for keeping track of the database’s most recent...
TransCelerate BioPharma which is an intriguing new big pharma collaboration was recently launched at a US trade show with the intentions of expediting the clinical research process. According to a recent article from Outsourcing-pharma.com , there are “five...
Watch for Pearl’s President and CEO highlighted in the Indiana University Center for the Business of Life Sciences video. The Kelley school has been holding quarterly events across the state with life science front-runners to consider, discuss, and debate...
A recent article by Xconomy explores the movement of biotech and the healthcare industry integrating their way into social media, Twitter specifically. Twitter is growing at a rapid pace and will appreciate approximately 250million users by the end of 2012. Gautam...
The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers...
The IMDMC 2012 annual conference will be held on Wednesday October 17, 2012 at the Montage Meeting Facility in Indianapolis, Indiana. Come equipped for a full day of events. The session features FDA’s Steve Silverman, Director, Office of Compliance, and CDRH. Pearl...