Pearl Pathways is a proud sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This series provides the opportunity for various industry professionals to discuss...
We are pleased to announce that Pearl Pathway’s own Gretchen Bowker will be presenting a webinar on preparing for an FDA audit in December for the Society of Clinical Research Sites. Clinical research sites for biopharma and medical device companies are seeing a...
Alexander Gaffney from raps.org has just released an article on regulators releasing the latest guideline on electronically transmitting individual case safety reports (ICSR) from the International Conference on Harmonisation’s (ICH). ICH is a pharmaceutical...
Uk.reuters.com just released an article about the lackluster number of approved drugs by FDA in 2013. In 2013 only 27 were approved vs. 39 in 2012, which was the most since 1997. FDA attributed the large decrease to fewer applications in 2013 which was down from 41 to...
David David Pittman from medpagetoday.com has written an article on FDA’s push to include sicker patients in clinical trials. In the article David brings up the new internal memo that requests drug reviewers to push for a broader population in trials. By doing this it...
Yevgeniy Feyman of Forbes has written an intriguing article entitled “Shocking Secrets of FDA Clinical Trials Revealed” the costs of bringing a new drug to market. Feyman shares that “according to Joseph Dimasi of the Tufts Center for the Study of Drug Development,...
